StrokeNCT06397170
Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients
A study testing Graded repetitive arm supplementary program and Task based training in people with Stroke and Upper Extremity Paresis, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine effects of graded repetitive arm supplementary program versus Task based training on Upper limb function in stroke patients. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis, Motor Activity
- What is being tested?
- Graded repetitive arm supplementary program and Task based training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 1 Sep 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with Sub acute stage of stroke.
- Patients with Ischemic and Haemorrhagic stroke.
- Patients with Cognition level on Mini Mental State Examination must be > 24
- Patients with mild pain in upper extremity according to Numeric Pain Rating Scale
- Patients with Grade 2 active movements in affected extremity Tone of upper limb at Modified Ashworth Scale Grade 1+.
Who cannot join
- Other neurological disorders e.g. brain tumor, encephalitis, meningitis, brain abscess.
- Use of antipsychotics
- Use of drugs for spasticity.
- Patients with vestibular impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients
To determine effects of graded repetitive arm supplementary program versus Task based training on Upper limb function in stroke patients.
Read the detailed description
This study will be Randomized Clinical Trial. A total of 38 stroke patients will be recruited by using non-probability convenience sampling Technique. Patients will be Randomized and allocated into two interventional groups based on the inclusion and exclusion criteria. Patients in Group A will receive Graded repetitive arm supplementary program and Patients in Group B will receive Task based training. All participants will receive the treatment for 40 minutes per session, 5 days per week for 5 weeks. For the evaluation of all participant scales like be Chedoke Arm and Hand Activity Inventory for clinical relevance, Fugl Mayer assessment scale for performance assessment, Action Reach Arm Test for coordination and dexterity and Motor Activity Log for functional assessment of Upper limb in stroke patients. D
- Conditions
- Stroke, Upper Extremity Paresis, Motor Activity
- Being tested
- Graded repetitive arm supplementary program, Task based training
- Keywords
- Stroke, Upper Extremity Paresis, Motor Activity
- Medical subject headings
- Stroke, Paresis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded repetitive arm supplementary programOther
Patients in Group A will receive Graded repetitive arm supplementary program
Task based trainingOther
Patients in Group B will receive Task based training.
| Study group | Role | What they receive |
|---|---|---|
| Graded repetitive arm supplementary program group | Experimental | Patients in Group A will receive Graded repetitive arm supplementary program. Receives: Other: Graded repetitive arm supplementary program |
| Task based training group | Active comparator | Patients in Group B will receive Task based training. Receives: Other: Task based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Mayer assessment scale
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. total score is 126.This tool has an excellent Inter- and intrarater reliability (intra class correlation coefficient = 0.98-0.99), validity is also excellent (r = 0.74-0.93, P < .0001). Higher scores indicate maximum recovery. higher the score greater is the improvement
Measured: 6 months
The Motor Activity Log (MAL)
The Motor Activity Log (MAL) is a subjective outcome measure of an individual's real life functional upper limb performance. The Motor activity log is administered by semi-structured interview and items are scored by patients according to their performance of each task over the past 7 days. The MAL adopts a 6-point ordinal scale, although patients can attribute a half-score, resulting in 11-point Likert scales with specified anchoring definitions at 6 points. higher the score greater is the improvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Model description
- Patients will be divided into Group A (N=19) will receive Graded repetitive arm supplementary program and Patients in Group B (N=19)will receive Task based training.
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeest hashmi, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397170
- Sponsor's protocol ID
- REC/RCR & AHS/23/0281
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Connell LA, McMahon NE, Watkins CL, Eng JJ. Therapists' use of the Graded Repetitive Arm Supplementary Program (GRASP) intervention: a practice implementation survey study. Phys Ther. 2014 May;94(5):632-43. doi: 10.2522/ptj.20130240. Epub 2014 Feb 6.
PubMed 24505098Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Yang CL, Waterson S, Eng JJ. Implementation and Evaluation of the Virtual Graded Repetitive Arm Supplementary Program (GRASP) for Individuals With Stroke During the COVID-19 Pandemic and Beyond. Phys Ther. 2021 Jun 1;101(6):pzab083. doi: 10.1093/ptj/pzab083.
PubMed 33682872Lee HS, Lim JH, Jeon BH, Song CS. Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial. Restor Neurol Neurosci. 2020;38(2):165-172. doi: 10.3233/RNN-190975.
PubMed 32176674
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT06397170
- Acronym / sponsor ID
- REC/RCR & AHS/23/0281
- Conditions
- Stroke, Upper Extremity Paresis, Motor Activity
- Keywords
- Stroke, Upper Extremity Paresis, Motor Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 2 May 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.
To determine effects of graded repetitive arm supplementary program versus Task based training on Upper limb function in stroke patients.
Detailed description
This study will be Randomized Clinical Trial. A total of 38 stroke patients will be recruited by using non-probability convenience sampling Technique. Patients will be Randomized and allocated into two interventional groups based on the inclusion and exclusion criteria. Patients in Group A will receive Graded repetitive arm supplementary program and Patients in Group B will receive Task based training. All participants will receive the treatment for 40 minutes per session, 5 days per week for 5 weeks. For the evaluation of all participant scales like be Chedoke Arm and Hand Activity Inventory for clinical relevance, Fugl Mayer assessment scale for performance assessment, Action Reach Arm Test for coordination and dexterity and Motor Activity Log for functional assessment of Upper limb in stroke patients. D
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be divided into Group A (N=19) will receive Graded repetitive arm supplementary program and Patients in Group B (N=19)will receive Task based training.
| Arm | Type | Receives |
|---|---|---|
| Graded repetitive arm supplementary program group | Experimental | Other: Graded repetitive arm supplementary programPatients in Group A will receive Graded repetitive arm supplementary program. |
| Task based training group | Active comparator | Other: Task based trainingPatients in Group B will receive Task based training. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with Sub acute stage of stroke.
- Patients with Ischemic and Haemorrhagic stroke.
- Patients with Cognition level on Mini Mental State Examination must be > 24
- Patients with mild pain in upper extremity according to Numeric Pain Rating Scale
- Patients with Grade 2 active movements in affected extremity Tone of upper limb at Modified Ashworth Scale Grade 1+.
Key exclusion criteria (4 listed)
- Other neurological disorders e.g. brain tumor, encephalitis, meningitis, brain abscess.
- Use of antipsychotics
- Use of drugs for spasticity.
- Patients with vestibular impairment.
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 |
|---|---|---|
| Graded repetitive arm supplementary programPatients in Group A will receive Graded repetitive arm supplementary program | Other | Graded repetitive arm supplementary program group |
| Task based trainingPatients in Group B will receive Task based training. | Other | Task based training group |
Primary outcome
Fugl Mayer assessment scale
Time frame: 6 months
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. total score is 126.This tool has an excellent Inter- and intrarater reliability (intra class correlation coefficient = 0.98-0.99), validity is also excellent (r = 0.74-0.93, P < .0001). Higher scores indicate maximum recovery. higher the score greater is the improvement
The Motor Activity Log (MAL)
Time frame: 6 months
The Motor Activity Log (MAL) is a subjective outcome measure of an individual's real life functional upper limb performance. The Motor activity log is administered by semi-structured interview and items are scored by patients according to their performance of each task over the past 7 days. The MAL adopts a 6-point ordinal scale, although patients can attribute a half-score, resulting in 11-point Likert scales with specified anchoring definitions at 6 points. higher the score greater is the improvement
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 19 Sep 2024.
- Background: PubMed 24505098Connell LA, McMahon NE, Watkins CL, Eng JJ. Therapists' use of the Graded Repetitive Arm Supplementary Program (GRASP) intervention: a practice implementation survey study. Phys Ther. 2014 May;94(5):632-43. doi: 10.2522/ptj.20130240. Epub 2014 Feb 6.
- Background: PubMed 24505342Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
- Background: PubMed 33682872Yang CL, Waterson S, Eng JJ. Implementation and Evaluation of the Virtual Graded Repetitive Arm Supplementary Program (GRASP) for Individuals With Stroke During the COVID-19 Pandemic and Beyond. Phys Ther. 2021 Jun 1;101(6):pzab083. doi: 10.1093/ptj/pzab083.
- Background: PubMed 32176674Lee HS, Lim JH, Jeon BH, Song CS. Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial. Restor Neurol Neurosci. 2020;38(2):165-172. doi: 10.3233/RNN-190975.
- 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.
Zeest hashmi 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 Graded repetitive arm supplementary program and Task based training in people with Stroke and Upper Extremity Paresis, 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 5 inclusion and 4 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 19 Sep 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 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?
Fugl Mayer assessment scale (time frame: 6 months). The study lists 2 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 NCT06397170, which also lists 4 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 19 Sep 2024.