Spinal Cord InjuryNCT05411692
Functional Electrical Stimulations With and Without Motor Priming Exercises in Spinal Cord Injury
A study testing Functional electrical stimulations and motor priming exercise, Functional electrical stimulations and Conventional physical therapy in people with Spinal Cord Injury, run by Riphah International University at 1 site in Pakistan.
Trial summary
As functional electrical stimulations has evident role in improving motor control in tenodesis function (power and precision grip) but its results are considered to be short term so addition of task oriented approach i.e. motor priming exercises could enhance the treatment effects . Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Functional electrical stimulations and motor priming exercise, Functional electrical stimulations and Conventional physical therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Mar 2022to 15 Nov 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both male and female with age group (15 50)
- Patient with C6-C7 neurological level of injury
- Patient with incomplete ASIA- D grading
- Clinically stable patients with normal vital signs and mental status
- Patient in acute and sub-acute stage ( usually < 18 months post injury
- Patients without active palmer and lateral grasp function (except tenodesis grasp function)
- Patients having intact wrist extensors in Grade 3 or higher manual muscle test i.e. can perform tenodesis action
Who cannot join
- Patients with Neurological level of injury C8 or above
- Patient with chronic stage > 18 months
- Patients with Spastic hands
- Patients with implants in body
- Patients with history of Epilepsy
- Patients with Cardiovascular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Functional Electrical Stimulations With and Without Motor Priming Exercises on Tenodesis Grip in Patients With Spinal Cord Injury
As functional electrical stimulations has evident role in improving motor control in tenodesis function (power and precision grip) but its results are considered to be short term so addition of task oriented approach i.e. motor priming exercises could enhance the treatment effects . Priming is a mechanism that could easily be a part of a restorative occupational therapy approach, is a therapeutic method with the intent to improve function by targeting underlying neural mechanisms (neuroplasticity and motor control). This will yield the long term effects of priming augmented functional electrical stimulations to enhance the tenodesis function of patients with spinal cord injury. Their combination may produce improvement in hand functions dexterity in spinal cord injury patients.
Read the detailed description
Spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in or loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cord, below the level of the injury. People with Spinal cord injury (C6-7 tetraplegia) are often lacking grip strength, causing impairment in activities of daily living. Variety of physiotherapy approaches such as electrical stimulations and different exercise regimes has been used in rehabilitation program of spinal cord injuries. Functional electrical impulses apply to nerves and muscles to restore muscle function in people with spinal cord injury. Second, priming of the motor cortex with motor priming exercises is associated with neuroplastic changes and improved motor performance.
This will be a randomized control trail and the study aims to determine which group will show better results of functional electrical stimulations with or without motor priming exercise on tenodesis grip in sub acute spinal cord injury patients. Evidences support that, in more than 40 years of functional electrical stimulation research, principles for safe stimulation of neuromuscular tissue have been established; it has been developed for restoring function in the upper extremity, lower extremity, bladder and bowel, and respiratory system. Paralyzed or paretic muscles can be made to contract by applying
electrical currents to the intact peripheral motor nerves innervating them. When electrically elicited muscle contractions are coordinated in a manner that provides function, the technique is termed functional electrical stimulation (FES)
Another approach is Motor priming, which is receiving considerable attention as a way of augmenting the effects of rehabilitation-related training in neurologic clinical populations. Much of the early work related to motor priming to improve hand function in persons with tetraplegia) Priming is a non-conscious process associated with learning where exposure to a stimulus alters the response of another stimulus. When used successfully in conjunction with a therapeutic intervention, priming results in a behavior change coinciding with changes in neural processes. Motor priming exercises demonstrate changes in cortical excitability, or facilitate cognitive processing, thus inducing neuroplastic effects such as release of neurochemicals that may enhance the effect of subsequent training. Priming that target the motor cortex is a relatively new topic of research in the fields of motor control and rehabilitation
This will be a randomized control trial and patients will be recruited through convenient sampling into three groups. Group A will be given functional electrical stimulations with motor priming exercises. Group B will be receiving functional electrical stimulations alone and group C will receive conventional exercises training. Pre and post measurements with outcome measuring tool will be taken. Tools for accessing tenodesis grip will be hand dynamometer, pinch meter, Manual Muscle Testing, graded redefined assessment of sensation , strength and pretension; GRASSP tool, Spinal Cord Independence Measure SCIM- self care sub score . The data will be analyzed using SPSS 25 software.
- Conditions
- Spinal Cord Injury
- Being tested
- Functional electrical stimulations and motor priming exercise, Functional electrical stimulations, Conventional physical therapy
- 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.
Functional electrical stimulations and motor priming exerciseOther
One pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median
nerve, to generate thumb flexion. The third pair of electrodes is placed on the subject's skin, above the extensor digitorum muscle, to generate finger extension. Motor priming exercises will be done (functional task practice, FTP) for 20 minutes. Participants will be asked to spend at least 20 minutesDuration of training will be 4 weeks, 5 days per week, one session per day, and one hour per session.
Functional electrical stimulationsOther
Stimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve. One pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median
nerve, to generate thumb flexion for 20 minutes
Conventional physical therapyOther
a structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training
| Study group | Role | What they receive |
|---|---|---|
| Functional electrical stimulations and motor priming exercise | Experimental | Functional electrical stimulations and motor priming exercise • Palmar Grasp (holding a ball) of Lateral Grasp (holding a tray),Tripod grip (thumb, index, and middle finger: holding a pen), Two finger opposition (thumb and index finger: holding a peg, Lateral Pinch (thumb and index finger: holding a credit card), lateral pinch, two fingers (index and middle finger: smoker's grip Receives: Other: Functional electrical stimulations and motor priming exercise |
| Functional electrical stimulations | Active comparator | Stimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve Receives: Other: Functional electrical stimulations |
| Convetional phyusical therapy | Placebo comparator | The prescription of resistance load for strength training will be performed with fine motor exercise , based on sub maximal repetitions Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand Dynamometer
Used to measure grip strength.The patient squeezes the dynamometer with all of their strength, typically three times with each hand. An average score is then calculated using the measurements from both hands
Measured: 6th week
Pinch meter
A pinch meter is a medical instrument that is used to test digital strength in the form of three different types of pinches. It primarily serves as a diagnostic and assessment tool.The therapist takes the average of 3 trials for each type of pinch, alternating from one hand to the other. Positioning during the test should be shoulder adducted, elbow at 90 degrees and forearm in neutral
Measured: 6th week
The American Spinal Injury Association Impairment Scale
The American Spinal Injury Association Impairment Scale is a standardized neurological examination used by the rehabilitation team to assess the sensory and motor levels which were affected by the spinal cord injury
Measured: 6th week
Graded redefined assessment for sensation, strength and prehension tool
The GRASSP is a clinical impairment measure used for the upper limb after tetraplegia. The measure includes three domains (sensation, strength , prehension) which are important in describing hand function(
Measured: 6th week
Secondary outcomes (1)
Spinal Cord Independence Measure
The SCIM has been developed to address three specific areas of function in
patients with spinal cord injury (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities i.e. bed mobility and transfers and indoors/outdoors
Measured: 6th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start15 Mar 2022
- Primary completion20 Sep 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 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 lahore campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411692
- Sponsor's protocol ID
- REC/RCR&AHS/22/0214
- Status last verified
- Jul 2023
- First submitted
- 6 Jun 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):56-87. doi: 10.1016/S1474-4422(18)30415-0. Epub 2018 Nov 26.
PubMed 30497965Jung HY, Lee J, Shin HI. The natural course of passive tenodesis grip in individuals with spinal cord injury with preserved wrist extension power but paralyzed fingers and thumbs. Spinal Cord. 2018 Sep;56(9):900-906. doi: 10.1038/s41393-018-0137-4. Epub 2018 May 22.
PubMed 29789707Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.
PubMed 16004574Stoykov ME, Corcos DM, Madhavan S. Movement-Based Priming: Clinical Applications and Neural Mechanisms. J Mot Behav. 2017 Jan-Feb;49(1):88-97. doi: 10.1080/00222895.2016.1250716. Epub 2017 Mar 1.
PubMed 28277966Vafadar AK, Cote JN, Archambault PS. Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:729768. doi: 10.1155/2015/729768. Epub 2015 Jan 22.
PubMed 25685805Sivaramakrishnan A, Madhavan S. Combining transcranial direct current stimulation with aerobic exercise to optimize cortical priming in stroke. Appl Physiol Nutr Metab. 2021 May;46(5):426-435. doi: 10.1139/apnm-2020-0677. Epub 2020 Oct 23.
PubMed 33095999Gomes-Osman J, Tibbett JA, Poe BP, Field-Fote EC. Priming for Improved Hand Strength in Persons with Chronic Tetraplegia: A Comparison of Priming-Augmented Functional Task Practice, Priming Alone, and Conventional Exercise Training. Front Neurol. 2017 Jan 17;7:242. doi: 10.3389/fneur.2016.00242. eCollection 2016.
PubMed 28144229Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
PubMed 29164023Mangold S, Keller T, Curt A, Dietz V. Transcutaneous functional electrical stimulation for grasping in subjects with cervical spinal cord injury. Spinal Cord. 2005 Jan;43(1):1-13. doi: 10.1038/sj.sc.3101644.
PubMed 15289804El Masry WS, Tsubo M, Katoh S, El Miligui YH, Khan A. Validation of the American Spinal Injury Association (ASIA) motor score and the National Acute Spinal Cord Injury Study (NASCIS) motor score. Spine (Phila Pa 1976). 1996 Mar 1;21(5):614-9. doi: 10.1097/00007632-199603010-00015.
PubMed 8852318Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. doi: 10.1038/sj.sc.3101822.
PubMed 16130018
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Electrical Stimulations With and Without Motor Priming Exercises on Tenodesis Grip in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05411692
- Acronym / sponsor ID
- REC/RCR&AHS/22/0214
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 9 Jun 2022 (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.
As functional electrical stimulations has evident role in improving motor control in tenodesis function (power and precision grip) but its results are considered to be short term so addition of task oriented approach i.e. motor priming exercises could enhance the treatment effects . Priming is a mechanism that could easily be a part of a restorative occupational therapy approach, is a therapeutic method with the intent to improve function by targeting underlying neural mechanisms (neuroplasticity and motor control). This will yield the long term effects of priming augmented functional electrical stimulations to enhance the tenodesis function of patients with spinal cord injury. Their combination may produce improvement in hand functions dexterity in spinal cord injury patients.
Detailed description
Spinal cord injury (SCI) is damage to the spinal cord that causes temporary or permanent changes in or loss of muscle function, sensation, or autonomic function in the parts of the body served by the spinal cord, below the level of the injury. People with Spinal cord injury (C6-7 tetraplegia) are often lacking grip strength, causing impairment in activities of daily living. Variety of physiotherapy approaches such as electrical stimulations and different exercise regimes has been used in rehabilitation program of spinal cord injuries. Functional electrical impulses apply to nerves and muscles to restore muscle function in people with spinal cord injury. Second, priming of the motor cortex with motor priming exercises is associated with neuroplastic changes and improved motor performance.
This will be a randomized control trail and the study aims to determine which group will show better results of functional electrical stimulations with or without motor priming exercise on tenodesis grip in sub acute spinal cord injury patients. Evidences support that, in more than 40 years of functional electrical stimulation research, principles for safe stimulation of neuromuscular tissue have been established; it has been developed for restoring function in the upper extremity, lower extremity, bladder and bowel, and respiratory system. Paralyzed or paretic muscles can be made to contract by applying
electrical currents to the intact peripheral motor nerves innervating them. When electrically elicited muscle contractions are coordinated in a manner that provides function, the technique is termed functional electrical stimulation (FES)
Another approach is Motor priming, which is receiving considerable attention as a way of augmenting the effects of rehabilitation-related training in neurologic clinical populations. Much of the early work related to motor priming to improve hand function in persons with tetraplegia) Priming is a non-conscious process associated with learning where exposure to a stimulus alters the response of another stimulus. When used successfully in conjunction with a therapeutic intervention, priming results in a behavior change coinciding with changes in neural processes. Motor priming exercises demonstrate changes in cortical excitability, or facilitate cognitive processing, thus inducing neuroplastic effects such as release of neurochemicals that may enhance the effect of subsequent training. Priming that target the motor cortex is a relatively new topic of research in the fields of motor control and rehabilitation
This will be a randomized control trial and patients will be recruited through convenient sampling into three groups. Group A will be given functional electrical stimulations with motor priming exercises. Group B will be receiving functional electrical stimulations alone and group C will receive conventional exercises training. Pre and post measurements with outcome measuring tool will be taken. Tools for accessing tenodesis grip will be hand dynamometer, pinch meter, Manual Muscle Testing, graded redefined assessment of sensation , strength and pretension; GRASSP tool, Spinal Cord Independence Measure SCIM- self care sub score . The data will be analyzed using SPSS 25 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Functional electrical stimulations and motor priming exercise | Experimental | Other: Functional electrical stimulations and motor priming exerciseFunctional electrical stimulations and motor priming exercise • Palmar Grasp (holding a ball) of Lateral Grasp (holding a tray),Tripod grip (thumb, index, and middle finger: holding a pen), Two finger opposition (thumb and index finger: holding a peg, Lateral Pinch (thumb and index finger: holding a credit card), lateral pinch, two fingers (index and middle finger: smoker's grip |
| Functional electrical stimulations | Active comparator | Other: Functional electrical stimulationsStimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve |
| Convetional phyusical therapy | Placebo comparator | Other: Conventional physical therapyThe prescription of resistance load for strength training will be performed with fine motor exercise , based on sub maximal repetitions |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Both male and female with age group (15 50)
- Patient with C6-C7 neurological level of injury
- Patient with incomplete ASIA- D grading
- Clinically stable patients with normal vital signs and mental status
- Patient in acute and sub-acute stage ( usually < 18 months post injury
Key exclusion criteria (6 listed)
- Patients with Neurological level of injury C8 or above
- Patient with chronic stage > 18 months
- Patients with Spastic hands
- Patients with implants in body
- Patients with history of Epilepsy
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 |
|---|---|---|
| Functional electrical stimulations and motor priming exerciseOne pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median nerve, to generate thumb flexion. The third pair of electrodes is placed on the subject's skin, above the extensor digitorum muscle, to generate finger extension. Motor priming exercises will be done (functional task practice, FTP) for 20 minutes. Participants will be asked to spend at least 20 minutesDuration of training will be 4 weeks, 5 days per week, one session per day, and one hour per session. | Other | Functional electrical stimulations and motor priming exercise |
| Functional electrical stimulationsStimulation parameters are (1) balanced, biphasic, current-regulated electrical pulses; (2) pulse amplitude from 8 to 50 mA (typical values 17- 26 mA); (3) pulse width 250 ms; and (4) pulse frequency from 20 to 70 Hz (18). Trancutaneous stimulation will be delivered bilaterally with surface electrodes placed on the volar aspect of each wrist targeting the distribution of the median nerve. One pair of surface stimulation electrodes is placed on the subject's skin above the flexor digitorum superficialis and the flexor digitorum profundus muscles to generate finger flexion. The Second pair of electrodes is placed on the subject's skin, above the median nerve, to generate thumb flexion for 20 minutes | Other | Functional electrical stimulations |
| Conventional physical therapya structured exercise protocol targeting strength (2 days/week) and endurance (3days/week) training | Other | Convetional phyusical therapy |
Primary outcome
Hand Dynamometer
Time frame: 6th week
Used to measure grip strength.The patient squeezes the dynamometer with all of their strength, typically three times with each hand. An average score is then calculated using the measurements from both hands
Pinch meter
Time frame: 6th week
A pinch meter is a medical instrument that is used to test digital strength in the form of three different types of pinches. It primarily serves as a diagnostic and assessment tool.The therapist takes the average of 3 trials for each type of pinch, alternating from one hand to the other. Positioning during the test should be shoulder adducted, elbow at 90 degrees and forearm in neutral
The American Spinal Injury Association Impairment Scale
Time frame: 6th week
The American Spinal Injury Association Impairment Scale is a standardized neurological examination used by the rehabilitation team to assess the sensory and motor levels which were affected by the spinal cord injury
Graded redefined assessment for sensation, strength and prehension tool
Time frame: 6th week
The GRASSP is a clinical impairment measure used for the upper limb after tetraplegia. The measure includes three domains (sensation, strength , prehension) which are important in describing hand function(
1 secondary outcome
Spinal Cord Independence Measure
Time frame: 6th weeks
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 20 Jul 2023.
- Background: PubMed 30497965GBD 2016 Traumatic Brain Injury and Spinal Cord Injury Collaborators. Global, regional, and national burden of traumatic brain injury and spinal cord injury, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2019 Jan;18(1):56-87. doi: 10.1016/S1474-4422(18)30415-0. Epub 2018 Nov 26.
- Background: PubMed 29789707Jung HY, Lee J, Shin HI. The natural course of passive tenodesis grip in individuals with spinal cord injury with preserved wrist extension power but paralyzed fingers and thumbs. Spinal Cord. 2018 Sep;56(9):900-906. doi: 10.1038/s41393-018-0137-4. Epub 2018 May 22.
- Background: PubMed 16004574Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.
- Background: PubMed 28277966Stoykov ME, Corcos DM, Madhavan S. Movement-Based Priming: Clinical Applications and Neural Mechanisms. J Mot Behav. 2017 Jan-Feb;49(1):88-97. doi: 10.1080/00222895.2016.1250716. Epub 2017 Mar 1.
- Background: PubMed 25685805Vafadar AK, Cote JN, Archambault PS. Effectiveness of functional electrical stimulation in improving clinical outcomes in the upper arm following stroke: a systematic review and meta-analysis. Biomed Res Int. 2015;2015:729768. doi: 10.1155/2015/729768. Epub 2015 Jan 22.
- Background: PubMed 33095999Sivaramakrishnan A, Madhavan S. Combining transcranial direct current stimulation with aerobic exercise to optimize cortical priming in stroke. Appl Physiol Nutr Metab. 2021 May;46(5):426-435. doi: 10.1139/apnm-2020-0677. Epub 2020 Oct 23.
- Background: PubMed 28144229Gomes-Osman J, Tibbett JA, Poe BP, Field-Fote EC. Priming for Improved Hand Strength in Persons with Chronic Tetraplegia: A Comparison of Priming-Augmented Functional Task Practice, Priming Alone, and Conventional Exercise Training. Front Neurol. 2017 Jan 17;7:242. doi: 10.3389/fneur.2016.00242. eCollection 2016.
- Background: PubMed 29164023Burns AS, Marino RJ, Kalsi-Ryan S, Middleton JW, Tetreault LA, Dettori JR, Mihalovich KE, Fehlings MG. Type and Timing of Rehabilitation Following Acute and Subacute Spinal Cord Injury: A Systematic Review. Global Spine J. 2017 Sep;7(3 Suppl):175S-194S. doi: 10.1177/2192568217703084. Epub 2017 Sep 5.
- Background: PubMed 15289804Mangold S, Keller T, Curt A, Dietz V. Transcutaneous functional electrical stimulation for grasping in subjects with cervical spinal cord injury. Spinal Cord. 2005 Jan;43(1):1-13. doi: 10.1038/sj.sc.3101644.
- Background: PubMed 8852318El Masry WS, Tsubo M, Katoh S, El Miligui YH, Khan A. Validation of the American Spinal Injury Association (ASIA) motor score and the National Acute Spinal Cord Injury Study (NASCIS) motor score. Spine (Phila Pa 1976). 1996 Mar 1;21(5):614-9. doi: 10.1097/00007632-199603010-00015.
- Background: PubMed 16130018Popovic MR, Thrasher TA, Adams ME, Takes V, Zivanovic V, Tonack MI. Functional electrical therapy: retraining grasping in spinal cord injury. Spinal Cord. 2006 Mar;44(3):143-51. doi: 10.1038/sj.sc.3101822.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injury
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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 lahore campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulations and motor priming exercise, Functional electrical stimulations and Conventional physical therapy in people with Spinal Cord Injury, 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 7 inclusion and 6 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 20 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Hand Dynamometer (time frame: 6th week). The study lists 4 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 NCT05411692, which also lists 11 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 20 Jul 2023.