StrokeNCT05158543
Intensity Dependent Effects of 'FAST-Table' on Physical Performance in Stroke
A study testing conventional therapy, Task oriented training (moderate intensity) and Task oriented training (high intensity) in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
According to the World Health Organization (WHO), stroke is defined as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- conventional therapy, Task oriented training (moderate intensity) and Task oriented training (high intensity)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 25 Apr 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
- Both Genders
- Age between 40-60 years.
- ≥3 months post stroke.
- Middle \& anterior Cerebral Artery stroke
- 18-25 points Mild cognitive impairment Montreal Cognitive Assessment (MoCA)
- FMA UE and LE collectively motor score 50-70
- Modified Rankin scale 3-4
Who cannot join
- Inability to follow 2-step commands
- Ashworth scale 3-4
- Current participation in other stroke treatments
- Other neurological diagnoses, history of fall \& fractures
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensity-dependent Effects of 'Functional Activities Specific Training-Table' on Physical Performance in Stroke
According to the World Health Organization (WHO), stroke is defined as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". By applying this definition, transient ischemic attack (TIA), which is defined to last less than 24 hours, and patients with stroke symptoms caused by subdural hemorrhage, tumors, poisoning, or trauma, are excluded.Task-oriented training (TOT) involves active training of motor tasks performed within a clear functional context that includes complex whole task or pre-task movements of the whole limb or a limb segment. A high number of repetitions performed within a single session characterizes this training. According to the literature, TOT results in neuroplastic changes and is critical for improving motor and functional recovery. Task-specific training is based fundamentally on the concept that repeated practice results in learning a specific task. There is increasing evidence of neural plastic changes associated with repeated training, and several aspects of rehabilitation entail repetition of movement. Repeated motor practice has been demonstrated to decrease muscle weakness and spasticity and form the physiological foundation of motor learning. Repeated practice of challenging movement tasks results in larger brain representations of the practiced movement.
Read the detailed description
The effectiveness of a high-intensity task-oriented training (TOT) program seems related to higher intensity of practice and cardiorespiratory workload. Implementing a high number of repetitions and a high cardiorespiratory workload showed improvement in hemiparetic gait with feasibility and exceeds the effectiveness of a low-intensity physiotherapy program to walk capacity and walking speed. The Canadian Best Practice guidelines for rehabilitation recommend that patients should receive a minimum of three hours of task-oriented training, five days per week. However, Lee et al. stated that adhering to the repeated practices for a long duration of time often poses challenges to both stroke survivors and healthcare providers. Similarly, it is possible that within three hours one can do a few repetitions of TOT with long breaks in between and therefore, end up doing an inadequate number of repetitions than the number that may be required to attain the desired goal. It is possible within an hour to perform a large amount of TOT that would have undesired adverse effects such as fatigue and pain, which may subsequently affect recovery. The number of repetitions in a session of TOT, and the frequency of sessions per week that would promote motor learning in the upper extremity might differ from that of the lower extremity. Therefore, in administering TOT during stroke rehabilitation, the number of repetitions of TOT per treatment session may arguably be more useful than the number of hours covered while practicing. The effectiveness of the number of repetitions of TOT in a training session for stroke rehabilitation has been investigated in the literature; however, the studies were not in agreement on the number of repetitions of TOT per session required to produce the desired rehabilitation outcome for upper and lower extremities. Different studies have used varied numbers of repetitions per treatment session; however, the number of repetitions needed for optimal human learning without adverse effect is still contentious.
Previous literature has sufficient evidence about the effects of task-oriented training on the stroke population but there is limited evidence about the number of repetitions needed for optimal human learning without adverse effects is still unknown. Some studies compared the number of repetitions of tasks, some compared the number of sessions (single session/double session)/day or per week, some studies reported different duration per session, and some studies compared 3, 4, 6, 8 weeks duration. However, none of the studies have reported on all parameters of dosage at once. The current study aims to identify the effects of different dosages (standard, medium, and high intensity). Second, previous literature mainly focused on the repetition (reps) of a single task (mass practice), and limited functional tasks were available for practice, while the current study aims at providing more and more functional tasks with limited repetitions to maintain the interest level of patients for practice and allow for variability in task practice and to avoid the boredom that might come from performing ≥100 repetitions of a single task. Third, there is a variety of equipment available for stroke rehabilitation focusing on separate body domains, but no specific equipment focuses on complete stroke rehabilitation protocol. The current study aims to develop "Functional Activities Specific Training Table (FAST-Table), which will offer all functional tasks (whole-body rehabilitation protocol) on one table and this table will serve as an intervention and an assessment tool. Fourthly, previous literature has used a variety of tasks for stroke rehabilitation; the current study aims to develop 100 specific functional tasks for stroke to perform on FAST-table. 100 standard tasks for stroke, upper limb "30tasks*10 repetition of each task= 300 reps",lower limb "30tasks*10 repetition of each task= 300 reps",balance "30tasks*10 repetition of each task= 300 rep", cognition "10tasks*10 repetition of each task= 100 reps" and Total 1000 reps/session.
- Conditions
- Stroke
- Being tested
- conventional therapy, Task oriented training (moderate intensity), Task oriented training (high intensity)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
The conventional group will receive active and passive range of motion exercises, balance, and strength training for upper and lower limbs. One session per day, three sessions/week for total of 12 weeks.
Task oriented training (moderate intensity)Other
In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Single session/day, 4 sessions/week for 12 weeks.
Task oriented training (high intensity)Other
In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Two sessions/day, 5 sessions/week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | the control group will receive conventional intervention for upper and lower limb motor function \& balance. Receives: Other: conventional therapy |
| moderate intensity group | Experimental | this group will get task-oriented training with moderate intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks. Receives: Other: Task oriented training (moderate intensity) |
| high intensity group | Experimental | this group will get task-oriented training with high intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks. Receives: Other: Task oriented training (high intensity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Stroke-specific, performance-based impairment index. It assesses motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Measured: week 12
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) quantifies the motor function of the upper extremity (UE) through timed and functional tasks. The widely used version of the WMFT consists of 17 items. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items comprise analyzing movement quality when completing various tasks.
Measured: week 12
Time up and go test
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down.
Measured: week 12
Berg balance scale (BBS)
The Berg Balance Scale assesses the balance of patients with different neurological disorders. A subject's performance on each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.
Measured: week 12
Wisconsin gait scale
The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with hemiplegia following stroke. Interpretation:
- minimum score: 13.35
- maximum score: 42
- The higher the score the more seriously affected the gait
Measured: week 12
Secondary outcomes (2)
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia. A group published it in 2005 at McGill University, working for several years at memory clinics in Montreal.
Measured: week 12
Stroke- Specific Quality of life SS (QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with Stroke. Patients must respond to each question of the SS-QOL regarding the past week. It is a self-report scale containing 49 items in 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items) and Personality (3 items).
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start1 Jan 2023
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Nawaz Malik, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158543
- Sponsor's protocol ID
- REC/01201/Ayesha Afridi
- Status last verified
- May 2024
- First submitted
- 13 Dec 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.
PubMed 3335877Krishnamurthi RV, Moran AE, Forouzanfar MH, Bennett DA, Mensah GA, Lawes CM, Barker-Collo S, Connor M, Roth GA, Sacco R, Ezzati M, Naghavi M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of hemorrhagic stroke: a summary of findings from the GBD 2010 study. Glob Heart. 2014 Mar;9(1):101-6. doi: 10.1016/j.gheart.2014.01.003.
PubMed 25432119Watkins KE, Levack WMM, Rathore FA, Hay-Smith EJC. What would 'upscaling' involve? A qualitative study of international variation in stroke rehabilitation. BMC Health Serv Res. 2021 Apr 29;21(1):399. doi: 10.1186/s12913-021-06293-8.
PubMed 33926440Das SK, Banerjee TK, Biswas A, Roy T, Raut DK, Mukherjee CS, Chaudhuri A, Hazra A, Roy J. A prospective community-based study of stroke in Kolkata, India. Stroke. 2007 Mar;38(3):906-10. doi: 10.1161/01.STR.0000258111.00319.58. Epub 2007 Feb 1.
PubMed 17272773Thornton J. Stroke: "striking reductions" are seen in number of people with symptoms seeking help. BMJ. 2020 Apr 6;369:m1406. doi: 10.1136/bmj.m1406. No abstract available.
PubMed 32253176Farooq MU, Majid A, Reeves MJ, Birbeck GL. The epidemiology of stroke in Pakistan: past, present, and future. Int J Stroke. 2009 Oct;4(5):381-9. doi: 10.1111/j.1747-4949.2009.00327.x.
PubMed 19765127Syed NA, Khealani BA, Ali S, Hasan A, Akhtar N, Brohi H, Mozaffar T, Ahmed N, Hameed A, Baig SM, Wasay M. Ischemic stroke subtypes in Pakistan: the Aga Khan University Stroke Data Bank. J Pak Med Assoc. 2003 Dec;53(12):584-8.
PubMed 14765937Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.
PubMed 31017023Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim HS, Lee NH. Effect of Group-Task-Oriented Training on Gross and Fine Motor Function, and Activities of Daily Living in Children with Spastic Cerebral Palsy. Phys Occup Ther Pediatr. 2020;40(1):18-30. doi: 10.1080/01942638.2019.1642287. Epub 2019 Jul 24.
PubMed 31339403Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
PubMed 31164067Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.
PubMed 32861668Borschmann K, Hayward KS, Raffelt A, Churilov L, Kramer S, Bernhardt J. Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review. Stroke Res Treat. 2018 Oct 30;2018:8087372. doi: 10.1155/2018/8087372. eCollection 2018.
PubMed 30515288Lin SH, Dionne TP. Interventions to Improve Movement and Functional Outcomes in Adult Stroke Rehabilitation: Review and Evidence Summary. J Particip Med. 2018 Jan 18;10(1):e3. doi: 10.2196/jopm.8929.
PubMed 33052128Afridi A, Malik AN, Rathore FA. High-Intensity Functional Activities Specific Training (FAST) in Post-Stroke Rehabilitation: A Randomized Trial on Motor Recovery and Quality of Life Improvements. Physiother Res Int. 2025 Apr;30(2):e70064. doi: 10.1002/pri.70064.
PubMed 40285456
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity-dependent Effects of 'Functional Activities Specific Training-Table' on Physical Performance in Stroke
- ClinicalTrials.gov ID
- NCT05158543
- Acronym / sponsor ID
- REC/01201/Ayesha Afridi
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 15 Dec 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.
According to the World Health Organization (WHO), stroke is defined as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". By applying this definition, transient ischemic attack (TIA), which is defined to last less than 24 hours, and patients with stroke symptoms caused by subdural hemorrhage, tumors, poisoning, or trauma, are excluded.Task-oriented training (TOT) involves active training of motor tasks performed within a clear functional context that includes complex whole task or pre-task movements of the whole limb or a limb segment. A high number of repetitions performed within a single session characterizes this training. According to the literature, TOT results in neuroplastic changes and is critical for improving motor and functional recovery. Task-specific training is based fundamentally on the concept that repeated practice results in learning a specific task. There is increasing evidence of neural plastic changes associated with repeated training, and several aspects of rehabilitation entail repetition of movement. Repeated motor practice has been demonstrated to decrease muscle weakness and spasticity and form the physiological foundation of motor learning. Repeated practice of challenging movement tasks results in larger brain representations of the practiced movement.
Detailed description
The effectiveness of a high-intensity task-oriented training (TOT) program seems related to higher intensity of practice and cardiorespiratory workload. Implementing a high number of repetitions and a high cardiorespiratory workload showed improvement in hemiparetic gait with feasibility and exceeds the effectiveness of a low-intensity physiotherapy program to walk capacity and walking speed. The Canadian Best Practice guidelines for rehabilitation recommend that patients should receive a minimum of three hours of task-oriented training, five days per week. However, Lee et al. stated that adhering to the repeated practices for a long duration of time often poses challenges to both stroke survivors and healthcare providers. Similarly, it is possible that within three hours one can do a few repetitions of TOT with long breaks in between and therefore, end up doing an inadequate number of repetitions than the number that may be required to attain the desired goal. It is possible within an hour to perform a large amount of TOT that would have undesired adverse effects such as fatigue and pain, which may subsequently affect recovery. The number of repetitions in a session of TOT, and the frequency of sessions per week that would promote motor learning in the upper extremity might differ from that of the lower extremity. Therefore, in administering TOT during stroke rehabilitation, the number of repetitions of TOT per treatment session may arguably be more useful than the number of hours covered while practicing. The effectiveness of the number of repetitions of TOT in a training session for stroke rehabilitation has been investigated in the literature; however, the studies were not in agreement on the number of repetitions of TOT per session required to produce the desired rehabilitation outcome for upper and lower extremities. Different studies have used varied numbers of repetitions per treatment session; however, the number of repetitions needed for optimal human learning without adverse effect is still contentious.
Previous literature has sufficient evidence about the effects of task-oriented training on the stroke population but there is limited evidence about the number of repetitions needed for optimal human learning without adverse effects is still unknown. Some studies compared the number of repetitions of tasks, some compared the number of sessions (single session/double session)/day or per week, some studies reported different duration per session, and some studies compared 3, 4, 6, 8 weeks duration. However, none of the studies have reported on all parameters of dosage at once. The current study aims to identify the effects of different dosages (standard, medium, and high intensity). Second, previous literature mainly focused on the repetition (reps) of a single task (mass practice), and limited functional tasks were available for practice, while the current study aims at providing more and more functional tasks with limited repetitions to maintain the interest level of patients for practice and allow for variability in task practice and to avoid the boredom that might come from performing ≥100 repetitions of a single task. Third, there is a variety of equipment available for stroke rehabilitation focusing on separate body domains, but no specific equipment focuses on complete stroke rehabilitation protocol. The current study aims to develop "Functional Activities Specific Training Table (FAST-Table), which will offer all functional tasks (whole-body rehabilitation protocol) on one table and this table will serve as an intervention and an assessment tool. Fourthly, previous literature has used a variety of tasks for stroke rehabilitation; the current study aims to develop 100 specific functional tasks for stroke to perform on FAST-table. 100 standard tasks for stroke, upper limb "30tasks*10 repetition of each task= 300 reps",lower limb "30tasks*10 repetition of each task= 300 reps",balance "30tasks*10 repetition of each task= 300 rep", cognition "10tasks*10 repetition of each task= 100 reps" and Total 1000 reps/session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: conventional therapythe control group will receive conventional intervention for upper and lower limb motor function \& balance. |
| moderate intensity group | Experimental | Other: Task oriented training (moderate intensity)this group will get task-oriented training with moderate intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks. |
| high intensity group | Experimental | Other: Task oriented training (high intensity)this group will get task-oriented training with high intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Both Genders
- Age between 40-60 years.
- ≥3 months post stroke.
- Middle \& anterior Cerebral Artery stroke
- 18-25 points Mild cognitive impairment Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (5 listed)
- Inability to follow 2-step commands
- Ashworth scale 3-4
- Current participation in other stroke treatments
- Other neurological diagnoses, history of fall \& fractures
- pregnancy
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 |
|---|---|---|
| conventional therapyThe conventional group will receive active and passive range of motion exercises, balance, and strength training for upper and lower limbs. One session per day, three sessions/week for total of 12 weeks. | Other | Control Group |
| Task oriented training (moderate intensity)In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Single session/day, 4 sessions/week for 12 weeks. | Other | moderate intensity group |
| Task oriented training (high intensity)In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Two sessions/day, 5 sessions/week for 12 weeks. | Other | high intensity group |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: week 12
Stroke-specific, performance-based impairment index. It assesses motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Wolf Motor Function Test
Time frame: week 12
The Wolf Motor Function Test (WMFT) quantifies the motor function of the upper extremity (UE) through timed and functional tasks. The widely used version of the WMFT consists of 17 items. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items comprise analyzing movement quality when completing various tasks.
Time up and go test
Time frame: week 12
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down.
Berg balance scale (BBS)
Time frame: week 12
The Berg Balance Scale assesses the balance of patients with different neurological disorders. A subject's performance on each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.
Wisconsin gait scale
Time frame: week 12
The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with hemiplegia following stroke. Interpretation: * minimum score: 13.35 * maximum score: 42 * The higher the score the more seriously affected the gait
2 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: week 12
Stroke- Specific Quality of life SS (QOL)
Time frame: week 12
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 29 May 2024.
- Background: PubMed 3335877The World Health Organization MONICA Project (monitoring trends and determinants in cardiovascular disease): a major international collaboration. WHO MONICA Project Principal Investigators. J Clin Epidemiol. 1988;41(2):105-14. doi: 10.1016/0895-4356(88)90084-4.
- Background: PubMed 25432119Krishnamurthi RV, Moran AE, Forouzanfar MH, Bennett DA, Mensah GA, Lawes CM, Barker-Collo S, Connor M, Roth GA, Sacco R, Ezzati M, Naghavi M, Murray CJ, Feigin VL; Global Burden of Diseases, Injuries, and Risk Factors 2010 Study Stroke Expert Group. The global burden of hemorrhagic stroke: a summary of findings from the GBD 2010 study. Glob Heart. 2014 Mar;9(1):101-6. doi: 10.1016/j.gheart.2014.01.003.
- Background: PubMed 33926440Watkins KE, Levack WMM, Rathore FA, Hay-Smith EJC. What would 'upscaling' involve? A qualitative study of international variation in stroke rehabilitation. BMC Health Serv Res. 2021 Apr 29;21(1):399. doi: 10.1186/s12913-021-06293-8.
- Background: PubMed 17272773Das SK, Banerjee TK, Biswas A, Roy T, Raut DK, Mukherjee CS, Chaudhuri A, Hazra A, Roy J. A prospective community-based study of stroke in Kolkata, India. Stroke. 2007 Mar;38(3):906-10. doi: 10.1161/01.STR.0000258111.00319.58. Epub 2007 Feb 1.
- Background: PubMed 32253176Thornton J. Stroke: "striking reductions" are seen in number of people with symptoms seeking help. BMJ. 2020 Apr 6;369:m1406. doi: 10.1136/bmj.m1406. No abstract available.
- Background: PubMed 19765127Farooq MU, Majid A, Reeves MJ, Birbeck GL. The epidemiology of stroke in Pakistan: past, present, and future. Int J Stroke. 2009 Oct;4(5):381-9. doi: 10.1111/j.1747-4949.2009.00327.x.
- Background: PubMed 14765937Syed NA, Khealani BA, Ali S, Hasan A, Akhtar N, Brohi H, Mozaffar T, Ahmed N, Hameed A, Baig SM, Wasay M. Ischemic stroke subtypes in Pakistan: the Aga Khan University Stroke Data Bank. J Pak Med Assoc. 2003 Dec;53(12):584-8.
- Background: PubMed 31017023Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24.
- Background: PubMed 31339403Ko EJ, Sung IY, Moon HJ, Yuk JS, Kim HS, Lee NH. Effect of Group-Task-Oriented Training on Gross and Fine Motor Function, and Activities of Daily Living in Children with Spastic Cerebral Palsy. Phys Occup Ther Pediatr. 2020;40(1):18-30. doi: 10.1080/01942638.2019.1642287. Epub 2019 Jul 24.
- Background: PubMed 31164067Winstein C, Kim B, Kim S, Martinez C, Schweighofer N. Dosage Matters. Stroke. 2019 Jul;50(7):1831-1837. doi: 10.1161/STROKEAHA.118.023603. Epub 2019 Jun 5.
- Background: PubMed 32861668Tollar J, Nagy F, Csutoras B, Prontvai N, Nagy Z, Torok K, Blenyesi E, Vajda Z, Farkas D, Toth BE, Repa I, Moizs M, Sipos D, Kedves A, Kovacs A, Hortobagyi T. High Frequency and Intensity Rehabilitation in 641 Subacute Ischemic Stroke Patients. Arch Phys Med Rehabil. 2021 Jan;102(1):9-18. doi: 10.1016/j.apmr.2020.07.012. Epub 2020 Aug 27.
- Background: PubMed 30515288Borschmann K, Hayward KS, Raffelt A, Churilov L, Kramer S, Bernhardt J. Rationale for Intervention and Dose Is Lacking in Stroke Recovery Trials: A Systematic Review. Stroke Res Treat. 2018 Oct 30;2018:8087372. doi: 10.1155/2018/8087372. eCollection 2018.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
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.
Arshad Nawaz Malik, 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 conventional therapy, Task oriented training (moderate intensity) and Task oriented training (high intensity) in people with Stroke, 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 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 29 May 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-Meyer Assessment (FMA) (time frame: week 12). The study lists 5 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 NCT05158543, which also lists 14 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 29 May 2024.