Spinal Cord InjuriesNCT04823078
Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients
A study testing Activity base therapy and Strength training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
In our society spinal cord injury is a major problem.activity based therapy and conventional therapy has a potentional to improve upper limb strength and transfer in tetraplegic patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Activity base therapy and Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2019to 30 Mar 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with C6 to T1 tetraplegia.
- Both male and female patients were included
- Participants with traumatic spinal cord injury
- Participants with well oriented behavior were included
- Participants with complete and in complete spinal cord injury
- Participants of all times post injury and any initial sitting were included
Who cannot join
- Any intervention that measure effectiveness of external devices such as orthotics, frames sittings and chair positions
- Participants with severe neurological disorders, psychological problems and cognitive issues.
- Paraplegic participants or participants involved in gait or walking balance training over ground
- Participants with severe co morbidities and other medical complications
- Participants with pressure ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
In our society spinal cord injury is a major problem.activity based therapy and conventional therapy has a potentional to improve upper limb strength and transfer in tetraplegic patients.
The aim of this study is to determine the effects of activity based therapy versus conventional therapy to improve the upper limb strength and transfer in spinal cord injury.
Read more
The study design used was randomized clinical trial. The study was conducted at the paraplegic center Peshawar in 6 weeks after the approval of synopsis. A sample size of 16 participants was taken with complete and incomplete spinal cord injury received using lottery method. Subjects were randomly divided into 2 groups. Group A was treated with activity based therapy + baseline therapy and group B was treated with conventional therapy + baseline therapy. 8 subjects in each group. Pre and post treatment evaluation were done by using Spinal cord independence measure scale (SCIM) and International standards for neurological classification of spinal cord injury upper extremity measurement scale (ISNCSCI- UEMS).
Post spinal cord independence measure activity based group mean 26.87±12.87 and conventional group mean 31.50±23.82. The results indicate that conventional therapy and activity based therapy both are helpful in improving upper limb strength and transfer total spinal cord independence measure pre sig.0.96 and post sig.0.57.
Both activity based therapy and conventional therapy equally effective for improving the upper limb strength and transfer in spinal cord injury.
entional therapy.
Read the detailed description
Spinal cord is the cylindrical structure of nerve fibers and tissues that is enclosed in the spine and provides connection between the brain and all parts of the body. The spinal cord is particularly prone to injury. The spinal cord does not have the ability to repair other parts of the body, if it is damaged. A spinal cord injury happens when the spinal cord is affected by trauma, loss of its normal blood flow, or tumor or infection compression. Lesions in the spinal cord are described as either complete or incomplete.In a complete spinal cord injury, the body suffers complete loss of sensation and muscle control below the injury stage. In an incomplete injury to the spinal cord, there is a certain stay behind feature below injury point. In most cases all sides of the body are similarly affected. Neck injuries to the upper portion of the spinal cord can cause quadriplegia-paralysis of both arms and legs. If the spinal cord injury occurs lower in the back then it can only induce paraplegia-paralysis of both legs. The incidence of SCI to be between 13 and 33 cases per million per year, and their estimate of the incidence of SCI was between 110 and 1120 per million populations. Quadriplegia term refers to the motor and sensory function of cervical spinal cord because neurons inside the neuron damaged the spinal canal. Quadriplegia can cause in the arms, trunk, legs and pelvic organs. Not including brachial plexus or peripheral nervous injury.Trauma is the principal cause of spinal cord injury. Nearly half of the incidents are attributed to accidents involving motor vehicles. Certain forms of trauma include: falling to the spine from a height, stabbing or gunshot wound and sports injuries. Spinal cord damage may also be caused by tumor, infection, or inflammation caused by compression of the spinal cord. Many patients have normal backbone canal and a higher risk of spinal cord injurySome prognostic factors are related to survival, includes demographic, injury, and psychosocial variables. The most important prognostic factors are age and severity of injury including the level of the nervous system, the degree of damage integrity, and ventilator dependence Patients with spinal cord injury (SCI), especially those with higher levels of disease, rely on care and assistance in their daily activities, most of which are provided by informal caregivers. Where home caregivers are involved, low usage of home services is observed. Provides care based on a doctor's prescription based on care needs, assessed by a qualified service provider using standardized procedures.
- Conditions
- Spinal Cord Injuries
- Being tested
- Activity base therapy, Strength training
- 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.
Activity base therapyOther
activity based therapy
Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching.
Strength trainingOther
Strengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors
| Study group | Role | What they receive |
|---|---|---|
| Activity base therapy | Active comparator | Not described Receives: Other: Activity base therapy |
| Strength training | Other | Not described Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCIM spinal cord independance measure
The Spinal Cord Independence Measure version II (SCIM) was used to assess the ability to accomplish activities of daily living. This scale assesses three areas: (1) self-care (feeding, grooming, bathing, and dressing); (2) respiration and sphincter management; and (3) mobility (bed, transfers, and indoor/outdoor).18 The SCIM III has demonstrated high internal consistency (Cronbach's α = 0.77-0.91) and inter-rater reliability (ICC = 0.96). Moreover, it has shown responsiveness similar to the Functional Independence Measure (FIM).19-21 Ceiling effects were observed in three items: Feeding, Respiration, and Bed mobility, whereas floor effects were observed in 11 items: feeding, bathing (upper and lower body), dressing (upper and lower body), use of toilet, bed mobility, transfers from wheelchair (to bed, toilet, car, and ground), and stair management. changes from the baseline assessed.
Measured: 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start15 Jun 2019
- Primary completion20 Feb 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823078
- Sponsor's protocol ID
- REC/Lhr/19/1009 Namra Urooj
- Status last verified
- Mar 2021
- First submitted
- 26 Mar 2021
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nas K, Yazmalar L, Sah V, Aydin A, Ones K. Rehabilitation of spinal cord injuries. World J Orthop. 2015 Jan 18;6(1):8-16. doi: 10.5312/wjo.v6.i1.8. eCollection 2015 Jan 18.
PubMed 25621206Divanoglou A, Trok K, Jorgensen S, Hultling C, Sekakela K, Tasiemski T. Active Rehabilitation for persons with spinal cord injury in Botswana - effects of a community peer-based programme. Spinal Cord. 2019 Oct;57(10):897-905. doi: 10.1038/s41393-019-0300-6. Epub 2019 May 24.
PubMed 31127198Brogioli M, Schneider S, Popp WL, Albisser U, Brust AK, Velstra IM, Gassert R, Curt A, Starkey ML. Monitoring Upper Limb Recovery after Cervical Spinal Cord Injury: Insights beyond Assessment Scores. Front Neurol. 2016 Aug 31;7:142. doi: 10.3389/fneur.2016.00142. eCollection 2016.
PubMed 27630612Hachem LD, Ahuja CS, Fehlings MG. Assessment and management of acute spinal cord injury: From point of injury to rehabilitation. J Spinal Cord Med. 2017 Nov;40(6):665-675. doi: 10.1080/10790268.2017.1329076. Epub 2017 Jun 1.
PubMed 28571527Behrman AL, Ardolino EM, Harkema SJ. Activity-Based Therapy: From Basic Science to Clinical Application for Recovery After Spinal Cord Injury. J Neurol Phys Ther. 2017 Jul;41 Suppl 3(Suppl 3 IV STEP Spec Iss):S39-S45. doi: 10.1097/NPT.0000000000000184.
PubMed 28628595Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
PubMed 27809702Argetsinger LC, Singh G, Bickel SG, Calvery ML, Behrman AL. Spinal cord injury in infancy: activity-based therapy impact on health, function, and quality of life in chronic injury. Spinal Cord Ser Cases. 2020 Mar 10;6(1):13. doi: 10.1038/s41394-020-0261-1.
PubMed 32157078Behrman AL, Argetsinger LC, Roberts MT, Stout D, Thompson J, Ugiliweneza B, Trimble SA. Activity-Based Therapy Targeting Neuromuscular Capacity After Pediatric-Onset Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2019 Spring;25(2):132-149. doi: 10.1310/sci2502-132.
PubMed 31068745de Oliveira CQ, Middleton JW, Refshauge K, Davis GM. Activity-Based Therapy in a Community Setting for Independence, Mobility, and Sitting Balance for People With Spinal Cord Injuries. J Cent Nerv Syst Dis. 2019 Apr 12;11:1179573519841623. doi: 10.1177/1179573519841623. eCollection 2019.
PubMed 31019375
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Activity Based Therapy on Upper Limb Strength and Transfer in Spinal Cord Injury Patients
- ClinicalTrials.gov ID
- NCT04823078
- Acronym / sponsor ID
- REC/Lhr/19/1009 Namra Urooj
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 30 Mar 2021 (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.
In our society spinal cord injury is a major problem.activity based therapy and conventional therapy has a potentional to improve upper limb strength and transfer in tetraplegic patients.
The aim of this study is to determine the effects of activity based therapy versus conventional therapy to improve the upper limb strength and transfer in spinal cord injury.
The study design used was randomized clinical trial. The study was conducted at the paraplegic center Peshawar in 6 weeks after the approval of synopsis. A sample size of 16 participants was taken with complete and incomplete spinal cord injury received using lottery method. Subjects were randomly divided into 2 groups. Group A was treated with activity based therapy + baseline therapy and group B was treated with conventional therapy + baseline therapy. 8 subjects in each group. Pre and post treatment evaluation were done by using Spinal cord independence measure scale (SCIM) and International standards for neurological classification of spinal cord injury upper extremity measurement scale (ISNCSCI- UEMS).
Post spinal cord independence measure activity based group mean 26.87±12.87 and conventional group mean 31.50±23.82. The results indicate that conventional therapy and activity based therapy both are helpful in improving upper limb strength and transfer total spinal cord independence measure pre sig.0.96 and post sig.0.57.
Both activity based therapy and conventional therapy equally effective for improving the upper limb strength and transfer in spinal cord injury.
entional therapy.
Detailed description
Spinal cord is the cylindrical structure of nerve fibers and tissues that is enclosed in the spine and provides connection between the brain and all parts of the body. The spinal cord is particularly prone to injury. The spinal cord does not have the ability to repair other parts of the body, if it is damaged. A spinal cord injury happens when the spinal cord is affected by trauma, loss of its normal blood flow, or tumor or infection compression. Lesions in the spinal cord are described as either complete or incomplete.In a complete spinal cord injury, the body suffers complete loss of sensation and muscle control below the injury stage. In an incomplete injury to the spinal cord, there is a certain stay behind feature below injury point. In most cases all sides of the body are similarly affected. Neck injuries to the upper portion of the spinal cord can cause quadriplegia-paralysis of both arms and legs. If the spinal cord injury occurs lower in the back then it can only induce paraplegia-paralysis of both legs. The incidence of SCI to be between 13 and 33 cases per million per year, and their estimate of the incidence of SCI was between 110 and 1120 per million populations. Quadriplegia term refers to the motor and sensory function of cervical spinal cord because neurons inside the neuron damaged the spinal canal. Quadriplegia can cause in the arms, trunk, legs and pelvic organs. Not including brachial plexus or peripheral nervous injury.Trauma is the principal cause of spinal cord injury. Nearly half of the incidents are attributed to accidents involving motor vehicles. Certain forms of trauma include: falling to the spine from a height, stabbing or gunshot wound and sports injuries. Spinal cord damage may also be caused by tumor, infection, or inflammation caused by compression of the spinal cord. Many patients have normal backbone canal and a higher risk of spinal cord injurySome prognostic factors are related to survival, includes demographic, injury, and psychosocial variables. The most important prognostic factors are age and severity of injury including the level of the nervous system, the degree of damage integrity, and ventilator dependence Patients with spinal cord injury (SCI), especially those with higher levels of disease, rely on care and assistance in their daily activities, most of which are provided by informal caregivers. Where home caregivers are involved, low usage of home services is observed. Provides care based on a doctor's prescription based on care needs, assessed by a qualified service provider using standardized procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Activity base therapy | Active comparator | Other: Activity base therapy |
| Strength training | Other | Other: Strength training |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants with C6 to T1 tetraplegia.
- Both male and female patients were included
- Participants with traumatic spinal cord injury
- Participants with well oriented behavior were included
- Participants with complete and in complete spinal cord injury
Key exclusion criteria (5 listed)
- Any intervention that measure effectiveness of external devices such as orthotics, frames sittings and chair positions
- Participants with severe neurological disorders, psychological problems and cognitive issues.
- Paraplegic participants or participants involved in gait or walking balance training over ground
- Participants with severe co morbidities and other medical complications
- Participants with pressure ulcers.
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 |
|---|---|---|
| Activity base therapyactivity based therapy Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching. | Other | Activity base therapy |
| Strength trainingStrengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors | Other | Strength training |
Primary outcome
SCIM spinal cord independance measure
Time frame: 6th week
The Spinal Cord Independence Measure version II (SCIM) was used to assess the ability to accomplish activities of daily living. This scale assesses three areas: (1) self-care (feeding, grooming, bathing, and dressing); (2) respiration and sphincter management; and (3) mobility (bed, transfers, and indoor/outdoor).18 The SCIM III has demonstrated high internal consistency (Cronbach's α = 0.77-0.91) and inter-rater reliability (ICC = 0.96). Moreover, it has shown responsiveness similar to the Functional Independence Measure (FIM).19-21 Ceiling effects were observed in three items: Feeding, Respiration, and Bed mobility, whereas floor effects were observed in 11 items: feeding, bathing (upper and lower body), dressing (upper and lower body), use of toilet, bed mobility, transfers from wheelchair (to bed, toilet, car, and ground), and stair management. changes from the baseline assessed.
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 30 Mar 2021.
- Background: PubMed 25621206Nas K, Yazmalar L, Sah V, Aydin A, Ones K. Rehabilitation of spinal cord injuries. World J Orthop. 2015 Jan 18;6(1):8-16. doi: 10.5312/wjo.v6.i1.8. eCollection 2015 Jan 18.
- Background: PubMed 31127198Divanoglou A, Trok K, Jorgensen S, Hultling C, Sekakela K, Tasiemski T. Active Rehabilitation for persons with spinal cord injury in Botswana - effects of a community peer-based programme. Spinal Cord. 2019 Oct;57(10):897-905. doi: 10.1038/s41393-019-0300-6. Epub 2019 May 24.
- Background: PubMed 27630612Brogioli M, Schneider S, Popp WL, Albisser U, Brust AK, Velstra IM, Gassert R, Curt A, Starkey ML. Monitoring Upper Limb Recovery after Cervical Spinal Cord Injury: Insights beyond Assessment Scores. Front Neurol. 2016 Aug 31;7:142. doi: 10.3389/fneur.2016.00142. eCollection 2016.
- Background: PubMed 28571527Hachem LD, Ahuja CS, Fehlings MG. Assessment and management of acute spinal cord injury: From point of injury to rehabilitation. J Spinal Cord Med. 2017 Nov;40(6):665-675. doi: 10.1080/10790268.2017.1329076. Epub 2017 Jun 1.
- Background: PubMed 28628595Behrman AL, Ardolino EM, Harkema SJ. Activity-Based Therapy: From Basic Science to Clinical Application for Recovery After Spinal Cord Injury. J Neurol Phys Ther. 2017 Jul;41 Suppl 3(Suppl 3 IV STEP Spec Iss):S39-S45. doi: 10.1097/NPT.0000000000000184.
- Background: PubMed 27809702Quel de Oliveira C, Refshauge K, Middleton J, de Jong L, Davis GM. Effects of Activity-Based Therapy Interventions on Mobility, Independence, and Quality of Life for People with Spinal Cord Injuries: A Systematic Review and Meta-Analysis. J Neurotrauma. 2017 May 1;34(9):1726-1743. doi: 10.1089/neu.2016.4558. Epub 2016 Dec 20.
- Background: PubMed 32157078Argetsinger LC, Singh G, Bickel SG, Calvery ML, Behrman AL. Spinal cord injury in infancy: activity-based therapy impact on health, function, and quality of life in chronic injury. Spinal Cord Ser Cases. 2020 Mar 10;6(1):13. doi: 10.1038/s41394-020-0261-1.
- Background: PubMed 31068745Behrman AL, Argetsinger LC, Roberts MT, Stout D, Thompson J, Ugiliweneza B, Trimble SA. Activity-Based Therapy Targeting Neuromuscular Capacity After Pediatric-Onset Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2019 Spring;25(2):132-149. doi: 10.1310/sci2502-132.
- Background: PubMed 31019375de Oliveira CQ, Middleton JW, Refshauge K, Davis GM. Activity-Based Therapy in a Community Setting for Independence, Mobility, and Sitting Balance for People With Spinal Cord Injuries. J Cent Nerv Syst Dis. 2019 Apr 12;11:1179573519841623. doi: 10.1177/1179573519841623. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
Binash Afzal, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activity base therapy and Strength training in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 5 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 30 Mar 2021. 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 Pakistan. 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?
SCIM spinal cord independance measure (time frame: 6th week). 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 NCT04823078, which also lists 9 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 30 Mar 2021.