Spinal Cord InjuriesOCONHANDNCT05863988
FES and Upper Limb Loading Exercises Outcome Comparison on Hand Function in Spinal Cord Injury Patients
A study testing Functional Electrical Stimulation and Upper Limb Loading Exercises in people with Spinal Cord Injuries, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Functional Electrical Stimulation and Upper Limb Loading Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2023to 30 Oct 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with incomplete SCI at neurological level C5-T1 in subacute stage.
- Medically stable
- Able to tolerate the Functional Electrical stimulation without sustained autonomic dysreflexia
- A score greater than 16 in mini-mental test
Who cannot join
- Patients taking long term steroids
- patient having pre-existing injury on upper limb or hand
- Patients have had Previous participation in experimental trial for spinal cord injury
- Patients using Currently cardioactive medications
- Individuals who has had Tendon transfers, implanted devices bladder stimulation, chronic intrathecal infusions
- Individuals with Bleeding disorders.
- Amputation of any digit on target hand
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Bahawal Victoria Hospital Bahawalpur
Chak Eighty-seven -Twelve Left, Punjab Province
Aroosa Razaq, DPT
About this study
Official title: Effects Of Functional Electrical Stimulation Versus Upper Limb Loading Exercises on Grip Strength,Dexterity and Function in Patients With Spinal Cord Injury
This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury.
Read the detailed description
Spinal cord injury (SCI) is based on the concept that rehabilitative training recruits neuronal systems spinal cord injury that remain intact after the injury to take over the impaired function.Working in the field of rehabilitation of the spinal cord injured, presents many challenges. Every patient presents a new and specific challenge. The tetraplegics more so than the paraplegics as the result of loss of active function of their upper extremities in addition to loss of function in the trunk and lower extremities. This study will be conducted to assess the effects of functional electrical stimulation versus limb loading exercises on hand grip strength,dexterity and function in patients with subacute spinal cord injury.
trength,dexterity and function in patients with subacute spinal cord injury. The study will be randomized clinical trial. Participants will be randomly allocated in to two groups each group will have ten participants.. This study will be conducted in two Hospitals in Punjab pakistan. The group A Will receive functional electrical stimulation .The group B will receive upper limb loading exercises .Both groups will be given 30-45 min session 5 days per week for 8 weeks. The outcomes will be measured before and after giving treatment by using modified Action Research Arm Test (ARAT),Hand held dynamometry , Nine-Hole Peg Test (9HPT). The results will be calculated by using SPSS 23 version . Statistical tests will be applied according to the normality of the data either it will be parametric or non-parametric.
- Conditions
- Spinal Cord Injuries
- Being tested
- Functional Electrical Stimulation, Upper Limb Loading Exercises
- Keywords
- Dexterity,Functional Electrical Stimulation,Hand Function
- 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 StimulationOther
The group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks.
Upper Limb Loading ExercisesOther
The group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation &upper limb loading exercises | Active comparator | The group A Will receive functional electrical stimulation and conservative treatment 30-45 min session 5 days per week for 8 weeks. Receives: Other: Functional Electrical Stimulation |
| Functional Electrical Stimulation & Upper Limb Loading Exercises | Active comparator | The group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks. Receives: Other: Upper Limb Loading Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Action Research Arm Test
The ARAT has excellent reliability and low ceiling effects. It consists of 4 subtests, including grasp, grip, pinch, and gross movement. All tasks were scored on a 4-point scale from 0 to 3, where 0 reflects poor hand function and 3 reflects good hand function (maximum score, 57).
Measured: 8th week
Hand Held Dynamometry
A small portable device is held by the examiner and placed against the patient's limb .during a maximal isometric contraction. The device can be used to test hand muscle strength efficiently
Measured: 8th week
9 peg hole test
Nine-Hole Peg Test is administered by asking the client to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container.. The number of seconds it takes for the patient to complete the test.
Measured: 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start25 Feb 2023
- Primary completion18 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira jabeen, MS NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863988
- Sponsor's protocol ID
- REC/LHR/23/0214 Aroosa
- Acronym
- OCONHAND
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
PubMed 15672628Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
PubMed 15673842Hilton BJ, Anenberg E, Harrison TC, Boyd JD, Murphy TH, Tetzlaff W. Re-Establishment of Cortical Motor Output Maps and Spontaneous Functional Recovery via Spared Dorsolaterally Projecting Corticospinal Neurons after Dorsal Column Spinal Cord Injury in Adult Mice. J Neurosci. 2016 Apr 6;36(14):4080-92. doi: 10.1523/JNEUROSCI.3386-15.2016.
PubMed 27053214
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Functional Electrical Stimulation Versus Upper Limb Loading Exercises on Grip Strength,Dexterity and Function in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05863988
- Acronym / sponsor ID
- OCONHAND / REC/LHR/23/0214 Aroosa
- Conditions
- Spinal Cord Injuries
- Keywords
- Dexterity,Functional Electrical Stimulation,Hand Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (actual)
- Primary completion
- 18 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 18 May 2023 (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.
This study is conducted to assess the effectiveness of functional electrical stimulation Vs limb loading exercises on hand grip strength,dexterity and function in patients with subacute cervical spinal cord injury.
Detailed description
Spinal cord injury (SCI) is based on the concept that rehabilitative training recruits neuronal systems spinal cord injury that remain intact after the injury to take over the impaired function.Working in the field of rehabilitation of the spinal cord injured, presents many challenges. Every patient presents a new and specific challenge. The tetraplegics more so than the paraplegics as the result of loss of active function of their upper extremities in addition to loss of function in the trunk and lower extremities. This study will be conducted to assess the effects of functional electrical stimulation versus limb loading exercises on hand grip strength,dexterity and function in patients with subacute spinal cord injury.
trength,dexterity and function in patients with subacute spinal cord injury. The study will be randomized clinical trial. Participants will be randomly allocated in to two groups each group will have ten participants.. This study will be conducted in two Hospitals in Punjab pakistan. The group A Will receive functional electrical stimulation .The group B will receive upper limb loading exercises .Both groups will be given 30-45 min session 5 days per week for 8 weeks. The outcomes will be measured before and after giving treatment by using modified Action Research Arm Test (ARAT),Hand held dynamometry , Nine-Hole Peg Test (9HPT). The results will be calculated by using SPSS 23 version . Statistical tests will be applied according to the normality of the data either it will be parametric or non-parametric.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation &upper limb loading exercises | Active comparator | Other: Functional Electrical StimulationThe group A Will receive functional electrical stimulation and conservative treatment 30-45 min session 5 days per week for 8 weeks. |
| Functional Electrical Stimulation & Upper Limb Loading Exercises | Active comparator | Other: Upper Limb Loading ExercisesThe group B will receive upper limb loading exercises and conservative treatment 30-45 min session 5 days per week for 8 weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with incomplete SCI at neurological level C5-T1 in subacute stage.
- Medically stable
- Able to tolerate the Functional Electrical stimulation without sustained autonomic dysreflexia
- A score greater than 16 in mini-mental test
Key exclusion criteria (7 listed)
- Patients taking long term steroids
- patient having pre-existing injury on upper limb or hand
- Patients have had Previous participation in experimental trial for spinal cord injury
- Patients using Currently cardioactive medications
- Individuals who has had Tendon transfers, implanted devices bladder stimulation, chronic intrathecal infusions
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 StimulationThe group A will receive functional electrical stimulation 30-45 min session 5 days per week for 8 weeks. | Other | Functional Electrical Stimulation &upper limb loading exercises |
| Upper Limb Loading ExercisesThe group B will receive Upper Limb Loading Exercises 30-45 min session 5 days per week for 8 weeks. | Other | Functional Electrical Stimulation & Upper Limb Loading Exercises |
Primary outcome
Modified Action Research Arm Test
Time frame: 8th week
The ARAT has excellent reliability and low ceiling effects. It consists of 4 subtests, including grasp, grip, pinch, and gross movement. All tasks were scored on a 4-point scale from 0 to 3, where 0 reflects poor hand function and 3 reflects good hand function (maximum score, 57).
Hand Held Dynamometry
Time frame: 8th week
A small portable device is held by the examiner and placed against the patient's limb .during a maximal isometric contraction. The device can be used to test hand muscle strength efficiently
9 peg hole test
Time frame: 8th week
Nine-Hole Peg Test is administered by asking the client to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. Participants must then remove the pegs from the holes, one by one, and replace them back into the container.. The number of seconds it takes for the patient to complete the test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Background: PubMed 15672628Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Background: PubMed 15673842Beekhuizen KS, Field-Fote EC. Massed practice versus massed practice with stimulation: effects on upper extremity function and cortical plasticity in individuals with incomplete cervical spinal cord injury. Neurorehabil Neural Repair. 2005 Mar;19(1):33-45. doi: 10.1177/1545968305274517.
- Background: PubMed 27053214Hilton BJ, Anenberg E, Harrison TC, Boyd JD, Murphy TH, Tetzlaff W. Re-Establishment of Cortical Motor Output Maps and Spontaneous Functional Recovery via Spared Dorsolaterally Projecting Corticospinal Neurons after Dorsal Column Spinal Cord Injury in Adult Mice. J Neurosci. 2016 Apr 6;36(14):4080-92. doi: 10.1523/JNEUROSCI.3386-15.2016.
- 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.
Hira jabeen, MS NMPT 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 Functional Electrical Stimulation and Upper Limb Loading Exercises 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hira Jabeen, MS NMPT (03234116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Action Research Arm Test (time frame: 8th week). The study lists 3 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 NCT05863988, which also lists 3 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 18 May 2023.