Spinal Cord Injury at T7-T10 LevelHBRSCINCT06444672
Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
A study testing Home-based Rehabilitation program and Knee-Ankle-Foot-Orthosis in people with Spinal Cord Injury at T7-T10 Level and War Injuries Due to Bullets and Fragments, run by University of Mosul at 1 site in Iraq.
Trial summary
Background: The scarcity of resources for spinal cord injury (SCI) rehabilitation constitutes a significant obstacle, particularly in war-torn regions experiencing a rise in such injuries. Read more about this study
- Who is it for?
- Ages 18 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury at T7-T10 Level, War Injuries Due to Bullets and Fragments, Spinal Cord Injury L1- L5
- What is being tested?
- Home-based Rehabilitation program and Knee-Ankle-Foot-Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIraq
- Study dates
- 25 Sep 2021to 25 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Every patient has SCI resulting from the ISIS war and HE/SHE committed to implementing the HBRP without interruption and implements all instructions from the researcher supervising the program.
Who cannot join
- If any information and conditions above are not available.
Trial locations and contacts
1 site in 1 country.
About this study
Background: The scarcity of resources for spinal cord injury (SCI) rehabilitation constitutes a significant obstacle, particularly in war-torn regions experiencing a rise in such injuries. Implementing a home-based rehabilitative program (HBRP) tailored to patients' environmental, social, and financial contexts is crucial in mitigating this challenge. The authors investigated the effects of a 24-month HBRP on anthropometric measurements, muscular strength, sensory and motor function, and independence in participants transitioning from bed to walking following SCI.
Methods: Serial case study in a quasi-experimental design, the conducting was at the participants' homes. The participants were four patients with SCI (experimental group) and another two patients with SCI (control group). The interventions were a 24-month HBRP comprising strength, flexibility, and balance training, the outcome measures involved anthropometric measurements, muscle strength using a digital handheld dynamometer, muscle thickness, and cross-sectional area measured using magnetic resonance imaging, measured five walking tests, and the American Spinal Injury Association scale (ASIA) score for assess the sensory and motor score, and the Spinal Cord Independence Measure (SCIM).
Read the detailed description
Materials and Methods
The primary condition being studied:
Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No Sensory/Motor in S4-5
Participants
From (NRCODP), the authors accessed six participants with SCIs who participated voluntarily in this study (three males and one female; their mean age was 24.75 years). Those patients constituted the experimental group. Their injuries were classified as grade A according to the American Spinal Injury Association (ASIA) scale. Spinal cord damage was observed at T6, T8, L1, and L2. The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months. The control group comprised two volunteers (mean age 23.50 years) with SCIs at T9 and L1. These patients only served as a comparison for magnetic resonance imaging (MRI) findings.
This study was a case series that included a home-based therapeutic exercise program. Strength and ASIA- scales were assessed every 6 months. The walking evaluation was performed monthly for 10 months after the participants began using assistive devices. The final assessment was conducted at 24 months.
Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included using a rubber ball for balance and strength, as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices such as knee-ankle-foot orthoses (KAFO) performed walking exercises. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. However, precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs.
Walking tests. The 10-m walk test (WT), 2-min WT (2MWT), 4MWT, 6MWT, and Up \& GO (WT) were used when the participants reached the walking phase. These tests were used to assess walking speed improvement and endurance in patients with SCI. The investigators chose wide, suitable areas at participants' homes for walking assessments to adhere to test prerequisites. Essential equipment, including markers denoting starting and concluding points, was supplied and distinguished "Remember the following text: 'by colorful stickers'", stopwatches, and measuring tapes. Further, safety protocols were implemented to safeguard participants during test execution, and all tests were carried out according to the relevant standards.
In addition, a kinesthetic analysis approach was used, in which mental visualization played a pivotal role in patients who lack a sense of balance. Locally manufactured assistive devices (e.g., KAFO) were used, and coordination between doctors and the author ensured effective treatment and successful rehabilitation.
Outcome measures Anthropometric measurements, including the abdominal, pelvic, thigh, and leg circumference, were taken using a tape measure. Weight and height were measured using traditional scales. Patient measurements (weight, body mass index [BMI], and anthropometric measurements) were monitored every 6 months throughout the intervention period. The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months. The pre-HRBP and 24-month values were also compared. In addition, muscle strength was measured using a Micro-FET2 dynamometer (Hoggan Scientific LLC, Salt Lake City, UT), where the participants exerted maximum force against the device while the examiner provided resistance. The tests lasted a few seconds and were signalled by the commands "go" and "relax". The Spinal Cord Independence Measure (SCIM) includes the self-care (0-20), respiration and sphincter management (0-40), and mobility (0-40) sub-scores. Each area is scored according to its proportional weight in these patients' general activity. The final score ranges from 0 to 100, with a high score indicating higher independence, the authors assess the independence of participants during the 24 months of rehabilitation.
Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner (Elekta Unity™, Philips, Stockholm, Sweden), which is a modified 1.5 T Philips Ingenia (Best, The Netherlands). Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles. These measurements were repeated 8-9 months after the start of standing and walking training. Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization.
During MRI analysis, the initial peak corresponds to muscle density, while the subsequent peak indicates fat density, and the midpoint between these peaks delineates muscle from fat pixels. Calculations of CSAs were performed using the equations outlined by Gorge and Dudley. Muscle CSA (cm2) = ¼ of the total number of muscle pixels * ([field of view {FOV} / matrix size])2, and Intramuscular Fat (IMF) CSA (cm2) = ¼ of the total number of IMF pixels * ([FOV / matrix size])2. To normalize for skeletal muscle size discrepancies across groups, IMF CSA was expressed relative to skeletal muscle CSA: Relative IMF = ¼ of ([IMF CSA / muscle CSA] * 100).
Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance. The ES was quantified by Cohen's criteria. Additionally, paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores. SPSS version 24.0 (IBM Corp., Armonk, NY, USA) was used for all analyses. An alpha value <0.05 indicated statistical significance.
- Conditions
- Spinal Cord Injury at T7-T10 Level, War Injuries Due to Bullets and Fragments, Spinal Cord Injury L1- L5, Spinal Cord Injury No Sensory/Motor in S4-S5
- Being tested
- Home-based Rehabilitation program, Knee-Ankle-Foot-Orthosis
- Keywords
- Spinal cord Injury, Anthropometric Measures, Muscles Strength, Motor-Sensory Functions, Home-Based Rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Rehabilitation programOther
Also called HBRP
Home-based rehabilitation program The investigators used the ASIA scale to evaluate the sensory function and voluntary movement7. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices (such as knee-ankle-foot orthoses, KAFO) performed walking exercises.
Knee-Ankle-Foot-OrthosisDevice
Also called KAFO devices
It is used to assist the participant in holding his /her body weight on the lower limb through standing and walking
| Study group | Role | What they receive |
|---|---|---|
| HBRP | Experimental | The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. Receives: Other: Home-based Rehabilitation program; Device: Knee-Ankle-Foot-Orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
The abdominal, pelvic, thigh, and leg circumferences were taken using a tape measure depending on the centimeter (cm) unit from the lying down position. These measures were measured to determine the changes in morphological shape for those parts as a result of home-based rehabilitation for 24 months. This was done using repeated measures that included multiple axes, in addition to others, such as muscle strength. Certain anthropometric measurements, quantified in centimeters, were chosen to monitor alterations arising from the efficacy of the Home-Based Rehabilitation Program (HBRP). These selected measurements comprised Waist/Abdomen circumference, Pelvis circumference, Right/Left Thigh circumference, and Right/Left Leg circumference. Anthropometric parameters, encompassing the circumference of various body segments, were diligently documented through the application of a tape measure.
Measured: Every 6-month repeated measures follow-up for 24 months
Weight, height, and body mass index BMI
Encompassed weight and body mass index (BMI) was consistently tracked, with specific consideration given to injury-related factors. The height was measured in (cm), and the weight was measured by using traditional scales in (kg). Both weight and height were used to measure the body mass index (BMI). These measures were repeated every 6 months for 24 months to follow up the changes in body weight according to increasing the activity and metabolic in muscles after a home-based rehabilitation program (HBRP).
Measured: Every 6-month and follow-up for 24 months
The American Spinal Injury Association ( ASIA) scale
It was used to examine the sensory and motor function before and after starting a home-based rehabilitation program (HBRP). The clinical evaluation incorporated the application of the American Spinal Injury Association ( ASIA) scale to measure sensory perception and the potential for voluntary movement, the degree from (0-100) as following the guidelines. Furthermore, the ASIA scale was employed in alignment with an interval of HBRP to appraise participants' sensory and motor function levels to assess the effectiveness of the rehabilitation program, drawing parallels with the methodology utilized. Additionally, ASIA was executed to gauge sensory perception and the capacity for voluntary movement on both sides of the participants' bodies, following the framework outlined.
Measured: Every 6-month and follow-up for 24 months
Muscle strength
It involved the lower extremity, head, trunk, and pelvis muscle strength tests as a result of HBRP. Muscular strength was assessed in kilograms (kg) for muscles implicated in lower limb activities below the spinal lesion level, muscular strength was appraised for muscles linked to the Head, Trunk, and Pelvis, operating below the level of the spinal lesion. Utilizing the Micro-FET2 dynamometer by HOGGAN, participants exerted maximal force against the device while the examiner applied resistance to gauge muscle strength. These assessments are initiated through verbal commands ("Go" and "Relax").
Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks.
Measured: Every 6-month and follow-up for 24 months
Spinal Cord Independence Measure (SCIM)
The final score ranges from 0 to 100, with a high score indicating a higher independence. A scale was used to assess the level of independence during the 24 months of rehabilitation. This scale involves several items. Its scoring system is self-explanatory; therefore there isn't a manual to instruct the clinician in the scoring process. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility.
Measured: Every 6-month repeated measures follow-up for 24 months
Magnetic resonance imaging (MRI)
MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner, which is a modified 1.5 T Philips Ingenia. Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA) (mm2), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles.
Measured: 8-9 months after the start of standing and walking training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start25 Sep 2021
- Primary completion15 Oct 2021
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord Injury at T7-T10 LevelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Serial case study in a quasi-experimental design
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mosul
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sfax
- Responsible party
- Sponsor
- Investigators
- Munib A Fathe, PhD, Study chair, University of Mosul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444672
- Sponsor's protocol ID
- UMosul
- Acronym
- HBRSCI
- Status last verified
- May 2024
- First submitted
- 11 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After we complete the publication of this study, we will declare that our data and program will be available by request.
Publications
Akita S, Tokumoto H, Yamaji Y, Ishigaki T, Ogata H, Tezuka T, Kosaka K, Kuriyama M, Mitsukawa N. Comparison of Vectra three-dimensional stereophotogrammetry measurement and tape measurement in the evaluation of perioperative volume change of the lower abdomen in association with lymphatic microsurgery. Microsurgery. 2022 Jan;42(1):50-56. doi: 10.1002/micr.30688. Epub 2020 Nov 23.
PubMed 33230882Willi R, Widmer M, Merz N, Bastiaenen CHG, Zorner B, Bolliger M. Validity and reliability of the 2-minute walk test in individuals with spinal cord injury. Spinal Cord. 2023 Jan;61(1):15-21. doi: 10.1038/s41393-022-00847-1. Epub 2022 Aug 23.
PubMed 35999254Kirshblum S, Botticello A, Benedetto J, Donovan J, Marino R, Hsieh S, Wagaman N. A Comparison of Diagnostic Stability of the ASIA Impairment Scale Versus Frankel Classification Systems for Traumatic Spinal Cord Injury. Arch Phys Med Rehabil. 2020 Sep;101(9):1556-1562. doi: 10.1016/j.apmr.2020.05.016. Epub 2020 Jun 10.
PubMed 32531222Dubinski D, Kolesnyk V. War in Ukraine: a neurosurgical perspective. Acta Neurochir (Wien). 2022 Dec;164(12):3071-3074. doi: 10.1007/s00701-022-05388-3. Epub 2022 Oct 20.
PubMed 362643671. Jesus TS, Landry MD, Hoenig H, Kamenov K, Mills JA, Chatterji S, et al. Global need for physical rehabilitation: Systematic analysis from the global burden of disease study 2019. Lancet. 2020;396:2006-17. doi:10.1016/S0140-6736(20)32340-0
Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.
PubMed 27815685Mohr T, Andersen JL, Biering-Sorensen F, Galbo H, Bangsbo J, Wagner A, Kjaer M. Long-term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord. 1997 Jan;35(1):1-16. doi: 10.1038/sj.sc.3100343.
PubMed 9025213Frey VN, Renz N, Thomschewski A, Langthaler PB, Schalkwijk FJ Van, Trinka E, et al. applied sciences Influence of Sports on Cortical Connectivity in Patients with Spinal Cord Injury-A High-Density EEG Study. Appl Sci. 2023;13:9469. doi:10.3390/app13169469.
Waters RL, Yakura JS, Adkins RH, Sie I. Recovery following complete paraplegia. Arch Phys Med Rehabil. 1992 Sep;73(9):784-9.
PubMed 1514883Rahimi M, Torkaman G, Ghabaee M, Ghasem-Zadeh A. Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial. Spinal Cord. 2020 Jan;58(1):78-85. doi: 10.1038/s41393-019-0328-7. Epub 2019 Jul 16.
PubMed 31312016Taccola G, Sayenko D, Gad P, Gerasimenko Y, Edgerton VR. And yet it moves: Recovery of volitional control after spinal cord injury. Prog Neurobiol. 2018 Jan;160:64-81. doi: 10.1016/j.pneurobio.2017.10.004. Epub 2017 Nov 2.
PubMed 29102670Spungen AM, Asselin PK, Fineberg DB, Kornfeld SD, Harel NY. Exoskeletal-Assisted Walking for Persons with Motor-Complete Paraplegia. New York (NY): VA Rehabilitation Research and Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury. 2013;Feb 4;1-14. [accessed]. http://www.ryzur.com.cn/uploadfile/2016/0830/20160830115519272.pdf
Yang A, Asselin P, Knezevic S, Kornfeld S, Spungen AM. Assessment of In-Hospital Walking Velocity and Level of Assistance in a Powered Exoskeleton in Persons with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2015 Spring;21(2):100-9. doi: 10.1310/sci2102-100. Epub 2015 Apr 12.
PubMed 26364279Mehrholz J, Kugler J, Pohl M. Locomotor training for walking after spinal cord injury. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006676. doi: 10.1002/14651858.CD006676.pub3.
PubMed 23152239Richard-Denis A, Dionne A, Mputu PM, Mac-Thiong JM. Do all patients with functional motor-incomplete (AIS-D) traumatic spinal cord injury need specialized inpatient functional rehabilitation? A prospective observational cohort study proposing clinical criteria for home-based rehabilitation after acute care. J Spinal Cord Med. 2024 Sep;47(5):753-764. doi: 10.1080/10790268.2023.2200354. Epub 2023 Apr 21.
PubMed 37083554
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Home-Based Rehabilitation on Anthropometric Measures, Sensory-Motor Functions and Independence After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06444672
- Acronym / sponsor ID
- HBRSCI / UMosul
- Conditions
- Spinal Cord Injury at T7-T10 Level, War Injuries Due to Bullets and Fragments, Spinal Cord Injury L1- L5, Spinal Cord Injury No Sensory/Motor in S4-S5
- Keywords
- Spinal cord Injury, Anthropometric Measures, Muscles Strength, Motor-Sensory Functions, Home-Based Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MosulUniversity, hospital or other
- Collaborators
- University of Sfax
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: The scarcity of resources for spinal cord injury (SCI) rehabilitation constitutes a significant obstacle, particularly in war-torn regions experiencing a rise in such injuries. Implementing a home-based rehabilitative program (HBRP) tailored to patients' environmental, social, and financial contexts is crucial in mitigating this challenge. The authors investigated the effects of a 24-month HBRP on anthropometric measurements, muscular strength, sensory and motor function, and independence in participants transitioning from bed to walking following SCI.
Methods: Serial case study in a quasi-experimental design, the conducting was at the participants' homes. The participants were four patients with SCI (experimental group) and another two patients with SCI (control group). The interventions were a 24-month HBRP comprising strength, flexibility, and balance training, the outcome measures involved anthropometric measurements, muscle strength using a digital handheld dynamometer, muscle thickness, and cross-sectional area measured using magnetic resonance imaging, measured five walking tests, and the American Spinal Injury Association scale (ASIA) score for assess the sensory and motor score, and the Spinal Cord Independence Measure (SCIM).
Detailed description
Materials and Methods
The primary condition being studied:
Spinal Cord Injury Paraplegia according to ASIA-scale Type A Complete damage No Sensory/Motor in S4-5
Participants
From (NRCODP), the authors accessed six participants with SCIs who participated voluntarily in this study (three males and one female; their mean age was 24.75 years). Those patients constituted the experimental group. Their injuries were classified as grade A according to the American Spinal Injury Association (ASIA) scale. Spinal cord damage was observed at T6, T8, L1, and L2. The participants started receiving the HBRP intervention 4-6 months after injury and the program lasted 24 months. The control group comprised two volunteers (mean age 23.50 years) with SCIs at T9 and L1. These patients only served as a comparison for magnetic resonance imaging (MRI) findings.
This study was a case series that included a home-based therapeutic exercise program. Strength and ASIA- scales were assessed every 6 months. The walking evaluation was performed monthly for 10 months after the participants began using assistive devices. The final assessment was conducted at 24 months.
Home-based rehabilitation program The investigators used the ASIA scale to evaluate sensory function and voluntary movement. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included using a rubber ball for balance and strength, as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices such as knee-ankle-foot orthoses (KAFO) performed walking exercises. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs. During the 24 months, the program encountered technical obstacles during implementation, primarily related to the unavailability of suitable tools to optimize exercise performance while ensuring participant safety, especially during the first 6 months. However, precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks. Participants' families either purchased or received exercise equipment, and some devices were locally manufactured based on standard specifications. Participants facing negative psychological states due to motor challenges and monotony received psychological, faith-based, encouraging, and entertaining interventions, incorporating real-life success stories through video observations of individuals with SCIs.
Walking tests. The 10-m walk test (WT), 2-min WT (2MWT), 4MWT, 6MWT, and Up \& GO (WT) were used when the participants reached the walking phase. These tests were used to assess walking speed improvement and endurance in patients with SCI. The investigators chose wide, suitable areas at participants' homes for walking assessments to adhere to test prerequisites. Essential equipment, including markers denoting starting and concluding points, was supplied and distinguished "Remember the following text: 'by colorful stickers'", stopwatches, and measuring tapes. Further, safety protocols were implemented to safeguard participants during test execution, and all tests were carried out according to the relevant standards.
In addition, a kinesthetic analysis approach was used, in which mental visualization played a pivotal role in patients who lack a sense of balance. Locally manufactured assistive devices (e.g., KAFO) were used, and coordination between doctors and the author ensured effective treatment and successful rehabilitation.
Outcome measures Anthropometric measurements, including the abdominal, pelvic, thigh, and leg circumference, were taken using a tape measure. Weight and height were measured using traditional scales. Patient measurements (weight, body mass index [BMI], and anthropometric measurements) were monitored every 6 months throughout the intervention period. The ASIA scale was used to examine the sensory and motor function before stating HBRP and subsequently every 6 months. The pre-HRBP and 24-month values were also compared. In addition, muscle strength was measured using a Micro-FET2 dynamometer (Hoggan Scientific LLC, Salt Lake City, UT), where the participants exerted maximum force against the device while the examiner provided resistance. The tests lasted a few seconds and were signalled by the commands "go" and "relax". The Spinal Cord Independence Measure (SCIM) includes the self-care (0-20), respiration and sphincter management (0-40), and mobility (0-40) sub-scores. Each area is scored according to its proportional weight in these patients' general activity. The final score ranges from 0 to 100, with a high score indicating higher independence, the authors assess the independence of participants during the 24 months of rehabilitation.
Magnetic resonance imaging technical considerations MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner (Elekta Unity™, Philips, Stockholm, Sweden), which is a modified 1.5 T Philips Ingenia (Best, The Netherlands). Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles. These measurements were repeated 8-9 months after the start of standing and walking training. Previous research has already established the reliability and validity of MRI for measuring MT and its capability to detect and monitor muscle changes during immobilization.
During MRI analysis, the initial peak corresponds to muscle density, while the subsequent peak indicates fat density, and the midpoint between these peaks delineates muscle from fat pixels. Calculations of CSAs were performed using the equations outlined by Gorge and Dudley. Muscle CSA (cm2) = ¼ of the total number of muscle pixels * ([field of view {FOV} / matrix size])2, and Intramuscular Fat (IMF) CSA (cm2) = ¼ of the total number of IMF pixels * ([FOV / matrix size])2. To normalize for skeletal muscle size discrepancies across groups, IMF CSA was expressed relative to skeletal muscle CSA: Relative IMF = ¼ of ([IMF CSA / muscle CSA] * 100).
Statistical analysis Study outcomes were compared across time points using a one-way repeated-measures analysis of variance. The ES was quantified by Cohen's criteria. Additionally, paired sample t-tests were used to compare pre-and post-intervention MRI measures and ASIA scale scores. SPSS version 24.0 (IBM Corp., Armonk, NY, USA) was used for all analyses. An alpha value <0.05 indicated statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Serial case study in a quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| HBRP | Experimental | Other: Home-based Rehabilitation program, Device: Knee-Ankle-Foot-OrthosisThe HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. |
Who may qualify
- Ages
- 18 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Every patient has SCI resulting from the ISIS war and HE/SHE committed to implementing the HBRP without interruption and implements all instructions from the researcher supervising the program.
Key exclusion criteria (1 listed)
- If any information and conditions above are not available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Rehabilitation programAlso: HBRPHome-based rehabilitation program The investigators used the ASIA scale to evaluate the sensory function and voluntary movement7. The HBRP included whole-body training with various exercises for stretching, strength, endurance, and aerobic fitness. The treatment sessions were performed three times per week and had a 50-120-minute duration. The exercises were modified based on individual progress and included the use of a rubber ball for balance and strength as well as trunk flexibility, static balance, stability, and standing exercises. Participants who could stand with assistive devices (such as knee-ankle-foot orthoses, KAFO) performed walking exercises. | Other | HBRP |
| Knee-Ankle-Foot-OrthosisAlso: KAFO devicesIt is used to assist the participant in holding his /her body weight on the lower limb through standing and walking | Device | HBRP |
Primary outcome
Anthropometric measurements
Time frame: Every 6-month repeated measures follow-up for 24 months
The abdominal, pelvic, thigh, and leg circumferences were taken using a tape measure depending on the centimeter (cm) unit from the lying down position. These measures were measured to determine the changes in morphological shape for those parts as a result of home-based rehabilitation for 24 months. This was done using repeated measures that included multiple axes, in addition to others, such as muscle strength. Certain anthropometric measurements, quantified in centimeters, were chosen to monitor alterations arising from the efficacy of the Home-Based Rehabilitation Program (HBRP). These selected measurements comprised Waist/Abdomen circumference, Pelvis circumference, Right/Left Thigh circumference, and Right/Left Leg circumference. Anthropometric parameters, encompassing the circumference of various body segments, were diligently documented through the application of a tape measure.
Weight, height, and body mass index BMI
Time frame: Every 6-month and follow-up for 24 months
Encompassed weight and body mass index (BMI) was consistently tracked, with specific consideration given to injury-related factors. The height was measured in (cm), and the weight was measured by using traditional scales in (kg). Both weight and height were used to measure the body mass index (BMI). These measures were repeated every 6 months for 24 months to follow up the changes in body weight according to increasing the activity and metabolic in muscles after a home-based rehabilitation program (HBRP).
The American Spinal Injury Association ( ASIA) scale
Time frame: Every 6-month and follow-up for 24 months
It was used to examine the sensory and motor function before and after starting a home-based rehabilitation program (HBRP). The clinical evaluation incorporated the application of the American Spinal Injury Association ( ASIA) scale to measure sensory perception and the potential for voluntary movement, the degree from (0-100) as following the guidelines. Furthermore, the ASIA scale was employed in alignment with an interval of HBRP to appraise participants' sensory and motor function levels to assess the effectiveness of the rehabilitation program, drawing parallels with the methodology utilized. Additionally, ASIA was executed to gauge sensory perception and the capacity for voluntary movement on both sides of the participants' bodies, following the framework outlined.
Muscle strength
Time frame: Every 6-month and follow-up for 24 months
It involved the lower extremity, head, trunk, and pelvis muscle strength tests as a result of HBRP. Muscular strength was assessed in kilograms (kg) for muscles implicated in lower limb activities below the spinal lesion level, muscular strength was appraised for muscles linked to the Head, Trunk, and Pelvis, operating below the level of the spinal lesion. Utilizing the Micro-FET2 dynamometer by HOGGAN, participants exerted maximal force against the device while the examiner applied resistance to gauge muscle strength. These assessments are initiated through verbal commands ("Go" and "Relax"). Precautionary measures included creating a secure exercise environment within a furniture-free 2-meter square, employing safety belts, maintaining a safe distance, and involving participants' relatives for assistance, especially during the introduction of new and challenging motor tasks.
Spinal Cord Independence Measure (SCIM)
Time frame: Every 6-month repeated measures follow-up for 24 months
The final score ranges from 0 to 100, with a high score indicating a higher independence. A scale was used to assess the level of independence during the 24 months of rehabilitation. This scale involves several items. Its scoring system is self-explanatory; therefore there isn't a manual to instruct the clinician in the scoring process. Scores range from 0-100, where a score of 0 defines total dependence and a score of 100 is indicative of complete independence. Each subscale score is evaluated within the 100-point scale (self-care: 0-20; respiration and sphincter management: 0-40; mobility.
Magnetic resonance imaging (MRI)
Time frame: 8-9 months after the start of standing and walking training
MRI examinations were performed in the supine position using a hybrid 1.5 T MRI scanner, which is a modified 1.5 T Philips Ingenia. Long stair and T1 fat suppression sequences were used to investigate the utility of MRI in measuring changes in muscle volume, and anatomical cross-sectional area (CSA) (mm2), focusing on the rectus femoris (RF) and gluteus maximus (GM) muscles. Additionally, the MRIs included muscle thickness (MT) in (mm) and CSA measurements for the bilateral RF and GM muscles.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Background: PubMed 33230882Akita S, Tokumoto H, Yamaji Y, Ishigaki T, Ogata H, Tezuka T, Kosaka K, Kuriyama M, Mitsukawa N. Comparison of Vectra three-dimensional stereophotogrammetry measurement and tape measurement in the evaluation of perioperative volume change of the lower abdomen in association with lymphatic microsurgery. Microsurgery. 2022 Jan;42(1):50-56. doi: 10.1002/micr.30688. Epub 2020 Nov 23.
- Background: PubMed 35999254Willi R, Widmer M, Merz N, Bastiaenen CHG, Zorner B, Bolliger M. Validity and reliability of the 2-minute walk test in individuals with spinal cord injury. Spinal Cord. 2023 Jan;61(1):15-21. doi: 10.1038/s41393-022-00847-1. Epub 2022 Aug 23.
- Background: PubMed 32531222Kirshblum S, Botticello A, Benedetto J, Donovan J, Marino R, Hsieh S, Wagaman N. A Comparison of Diagnostic Stability of the ASIA Impairment Scale Versus Frankel Classification Systems for Traumatic Spinal Cord Injury. Arch Phys Med Rehabil. 2020 Sep;101(9):1556-1562. doi: 10.1016/j.apmr.2020.05.016. Epub 2020 Jun 10.
- Background: PubMed 36264367Dubinski D, Kolesnyk V. War in Ukraine: a neurosurgical perspective. Acta Neurochir (Wien). 2022 Dec;164(12):3071-3074. doi: 10.1007/s00701-022-05388-3. Epub 2022 Oct 20.
- Background1. Jesus TS, Landry MD, Hoenig H, Kamenov K, Mills JA, Chatterji S, et al. Global need for physical rehabilitation: Systematic analysis from the global burden of disease study 2019. Lancet. 2020;396:2006-17. doi:10.1016/S0140-6736(20)32340-0
- Results publication: PubMed 27815685Roberts TT, Leonard GR, Cepela DJ. Classifications In Brief: American Spinal Injury Association (ASIA) Impairment Scale. Clin Orthop Relat Res. 2017 May;475(5):1499-1504. doi: 10.1007/s11999-016-5133-4. Epub 2016 Nov 4. No abstract available.
- Results publication: PubMed 9025213Mohr T, Andersen JL, Biering-Sorensen F, Galbo H, Bangsbo J, Wagner A, Kjaer M. Long-term adaptation to electrically induced cycle training in severe spinal cord injured individuals. Spinal Cord. 1997 Jan;35(1):1-16. doi: 10.1038/sj.sc.3100343.
- Results publicationFrey VN, Renz N, Thomschewski A, Langthaler PB, Schalkwijk FJ Van, Trinka E, et al. applied sciences Influence of Sports on Cortical Connectivity in Patients with Spinal Cord Injury-A High-Density EEG Study. Appl Sci. 2023;13:9469. doi:10.3390/app13169469.
- Results publication: PubMed 1514883Waters RL, Yakura JS, Adkins RH, Sie I. Recovery following complete paraplegia. Arch Phys Med Rehabil. 1992 Sep;73(9):784-9.
- Results publication: PubMed 31312016Rahimi M, Torkaman G, Ghabaee M, Ghasem-Zadeh A. Advanced weight-bearing mat exercises combined with functional electrical stimulation to improve the ability of wheelchair-dependent people with spinal cord injury to transfer and attain independence in activities of daily living: a randomized controlled trial. Spinal Cord. 2020 Jan;58(1):78-85. doi: 10.1038/s41393-019-0328-7. Epub 2019 Jul 16.
- Results publication: PubMed 29102670Taccola G, Sayenko D, Gad P, Gerasimenko Y, Edgerton VR. And yet it moves: Recovery of volitional control after spinal cord injury. Prog Neurobiol. 2018 Jan;160:64-81. doi: 10.1016/j.pneurobio.2017.10.004. Epub 2017 Nov 2.
- Results publicationSpungen AM, Asselin PK, Fineberg DB, Kornfeld SD, Harel NY. Exoskeletal-Assisted Walking for Persons with Motor-Complete Paraplegia. New York (NY): VA Rehabilitation Research and Development National Center of Excellence for the Medical Consequences of Spinal Cord Injury. 2013;Feb 4;1-14. [accessed]. http://www.ryzur.com.cn/uploadfile/2016/0830/20160830115519272.pdf
- Individual participant dataSharing planned: Yes. After we complete the publication of this study, we will declare that our data and program will be available by request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munib A Fathe, PhD study chair
University of Mosul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Rehabilitation program and Knee-Ankle-Foot-Orthosis in people with Spinal Cord Injury at T7-T10 Level and War Injuries Due to Bullets and Fragments, run by University of Mosul at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric measurements (time frame: Every 6-month repeated measures follow-up for 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06444672, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.