StrokeMRPNCT06690073
The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation.
A study testing Motor Relearning Program and Conventional Physical Therapy in people with Stroke and Chronic Stroke Patients, run by University of Jazan at 1 site in Saudi Arabia.
Trial summary
1. To find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects. 2. To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among… Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Chronic Stroke Patients, Chronic Stroke Survivors
- What is being tested?
- Motor Relearning Program and Conventional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 4 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right or left-sided chronic hemiplegic subjects.
- More than six months after the onset of stroke.
- Age group between 45-65 years of both genders.
- Scored minimally 24/30 on the Mini-Mental State Exam (MMSE).
- Motor assessment scale of sitting to standing section.
- Having normal visual perception.
- Able to follow verbal commands.
Who cannot join
- Less than six months after the onset of stroke.
- Unable to follow visual and oral commands.
- The age group is below 45 years and more than 65 years.
- Unilateral neglect.
- Cognitive impairments (MMSE scores less than 24/30), or language deficits.
- Any other neurological disorders and recent surgeries.
- Previous exposure to MRP.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Saud Medical City
Riyadh, Riyadh Region
Khadijah Abdulrahman Alfaleh, MPT, 00966543997595, khadooj1411@hotmail.com
About this study
Official title: The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation
- To find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
- To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among chronic hemiplegic subjects.
- To find out the effectiveness of motor relearning program along with conventional physical therapy treatment over conventional physical therapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
Read the detailed description
After a careful monitor of inclusion and exclusion criteria and obtaining the institutional review board approval, the study was conducted by convenience sampling to select the suitable subjects, explaining the procedure to them, and got the written \& oral informed consent. The study included two groups, each with 16 participants, which were allocated randomly to the control and experimental groups by lottery method. CPT was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group. At the same time, the experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week.
MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft of the leg while moving it anteriorly through the affected foot.
MRP of standing to sitting: The participant was on his feet. The physiotherapist assisted the participant with anterior shoulder movement and knee bending at the start of the stand-to-sit movement. The physiotherapist then assisted the participant in keeping his weight on the affected leg while sitting. The subject progressed by standing and sitting with different seat heights, stopping in different parts of the range of motion, and varying speed. These variations in time and space were directed by the physical therapist. The number of reps and intensity of the exercise were classified according to the subject's capacity level and gradually increased as they improved. Subjects were given verbal feedback on weight distribution, performance speed, and encouragement.
- Conditions
- Stroke, Chronic Stroke Patients, Chronic Stroke Survivors, Hemiplegia
- Being tested
- Motor Relearning Program, Conventional Physical Therapy
- Keywords
- Stroke, Hemiplegia, Functional mobility, motor relearning program
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Relearning ProgramOther
Also called Conventional Physical Therapy
Total duration of the intervention is 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week.
MRP of sitting and standing activities: The physical therapist will instruct the participant, who will be seated in an armrest-equipped chair, to keep their feet back and position their trunk forward.. The participant will then be guided to press down through the affected foot, stand up quickly, and move their hips forward. The therapist will suggest pressing down through the participant's knee along the leg while moving it forward through the affected foot.
MRP of standing to sitting: The participant will stand while the physiotherapist assists with anterior shoulder movement and knee bending at the start of the transition. The therapist will then help maintain weight on the affected leg while sitting. The participant will progress by standing and sitting at different seat heights, stopping at various points in the ROM, and changing speed.
Conventional Physical TherapyOther
Conventional Physical Therapy (CPT) will be administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training will be given to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Conventional Physical Therapy (CPT) was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group. Receives: Other: Conventional Physical Therapy |
| Experimental | Experimental | the experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week.
MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft Receives: Other: Motor Relearning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barthel Index (BI)
The Barthel index, frequently used for stroke, gauges the level of help needed by an individual for ten mobility and daily living tasks. The total of all weighted individual item scores is converted into a single overall score, which ranges from 0 to 100. Consequently, "0" represents total independence from all ten activities. It takes 5 to 10 minutes to complete, has strong validity and reliability, and has minimal sensitivity for high-level functioning (Bhalerao et al., 2011).
Measured: week 0 and week 6
Motor Assessment Scale (MAS)
MAS is used to evaluate motor skills. MAS records eight functional activities: rolling in bed, sitting, sit to stand, walking, balancing in seated position, upper arm, hand, and wrist activities. The general tone of the body is noted in the ninth item. The scale for each item is 0 to 6. Hence, a score of 0 to 54 (normal function). According to WHO guidelines, MAS is supposed to be tested on the severity of disabilities. The MAS was highly dependable, with an average inter-rater reliability of .95 and an average test-retest reliability of 0.98 (Bhalerao et al., 2011).
Measured: week 0 and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start4 Nov 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Collaborators
- King Saud Medical City
- Responsible party
- Principal investigator, Karthick Balasubramanian, University of Jazan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690073
- Sponsor's protocol ID
- Apr.13/COM-2022/32-3
- Acronym
- MRP
- Status last verified
- Nov 2024
- First submitted
- 10 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alfaleh KA, Shaik AR, Balasubramanian K, Alshehri MM, Sanjeevi RR, Esht V, Alsalem WO, Shahhar AM, Alothman SA. Effectiveness of motor relearning program in sit-to-stand transfer and activities of daily living among chronic stroke patients - a prospective, multicenter, randomized controlled trial. J Comp Eff Res. 2026 Jan;15(1):e250133. doi: 10.57264/cer-2025-0133. Epub 2025 Dec 9.
PubMed 41363941
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06690073
- Acronym / sponsor ID
- MRP / Apr.13/COM-2022/32-3
- Conditions
- Stroke, Chronic Stroke Patients, Chronic Stroke Survivors, Hemiplegia
- Keywords
- Stroke, Hemiplegia, Functional mobility, motor relearning program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of JazanOther government
- Collaborators
- King Saud Medical City
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 15 Nov 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 find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
- To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among chronic hemiplegic subjects.
- To find out the effectiveness of motor relearning program along with conventional physical therapy treatment over conventional physical therapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
Detailed description
After a careful monitor of inclusion and exclusion criteria and obtaining the institutional review board approval, the study was conducted by convenience sampling to select the suitable subjects, explaining the procedure to them, and got the written \& oral informed consent. The study included two groups, each with 16 participants, which were allocated randomly to the control and experimental groups by lottery method. CPT was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group. At the same time, the experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week.
MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft of the leg while moving it anteriorly through the affected foot.
MRP of standing to sitting: The participant was on his feet. The physiotherapist assisted the participant with anterior shoulder movement and knee bending at the start of the stand-to-sit movement. The physiotherapist then assisted the participant in keeping his weight on the affected leg while sitting. The subject progressed by standing and sitting with different seat heights, stopping in different parts of the range of motion, and varying speed. These variations in time and space were directed by the physical therapist. The number of reps and intensity of the exercise were classified according to the subject's capacity level and gradually increased as they improved. Subjects were given verbal feedback on weight distribution, performance speed, and encouragement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Conventional Physical TherapyConventional Physical Therapy (CPT) was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group. |
| Experimental | Experimental | Other: Motor Relearning Programthe experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week. MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Right or left-sided chronic hemiplegic subjects.
- More than six months after the onset of stroke.
- Age group between 45-65 years of both genders.
- Scored minimally 24/30 on the Mini-Mental State Exam (MMSE).
- Motor assessment scale of sitting to standing section.
Key exclusion criteria (7 listed)
- Less than six months after the onset of stroke.
- Unable to follow visual and oral commands.
- The age group is below 45 years and more than 65 years.
- Unilateral neglect.
- Cognitive impairments (MMSE scores less than 24/30), or language deficits.
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 |
|---|---|---|
| Motor Relearning ProgramAlso: Conventional Physical TherapyTotal duration of the intervention is 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week. MRP of sitting and standing activities: The physical therapist will instruct the participant, who will be seated in an armrest-equipped chair, to keep their feet back and position their trunk forward.. The participant will then be guided to press down through the affected foot, stand up quickly, and move their hips forward. The therapist will suggest pressing down through the participant's knee along the leg while moving it forward through the affected foot. MRP of standing to sitting: The participant will stand while the physiotherapist assists with anterior shoulder movement and knee bending at the start of the transition. The therapist will then help maintain weight on the affected leg while sitting. The participant will progress by standing and sitting at different seat heights, stopping at various points in the ROM, and changing speed. | Other | Experimental |
| Conventional Physical TherapyConventional Physical Therapy (CPT) will be administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training will be given to the control group. | Other | Control |
Primary outcome
Barthel Index (BI)
Time frame: week 0 and week 6
The Barthel index, frequently used for stroke, gauges the level of help needed by an individual for ten mobility and daily living tasks. The total of all weighted individual item scores is converted into a single overall score, which ranges from 0 to 100. Consequently, "0" represents total independence from all ten activities. It takes 5 to 10 minutes to complete, has strong validity and reliability, and has minimal sensitivity for high-level functioning (Bhalerao et al., 2011).
Motor Assessment Scale (MAS)
Time frame: week 0 and week 6
MAS is used to evaluate motor skills. MAS records eight functional activities: rolling in bed, sitting, sit to stand, walking, balancing in seated position, upper arm, hand, and wrist activities. The general tone of the body is noted in the ninth item. The scale for each item is 0 to 6. Hence, a score of 0 to 54 (normal function). According to WHO guidelines, MAS is supposed to be tested on the severity of disabilities. The MAS was highly dependable, with an average inter-rater reliability of .95 and an average test-retest reliability of 0.98 (Bhalerao et al., 2011).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 41363941Alfaleh KA, Shaik AR, Balasubramanian K, Alshehri MM, Sanjeevi RR, Esht V, Alsalem WO, Shahhar AM, Alothman SA. Effectiveness of motor relearning program in sit-to-stand transfer and activities of daily living among chronic stroke patients - a prospective, multicenter, randomized controlled trial. J Comp Eff Res. 2026 Jan;15(1):e250133. doi: 10.57264/cer-2025-0133. Epub 2025 Dec 9.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Relearning Program and Conventional Physical Therapy in people with Stroke and Chronic Stroke Patients, run by University of Jazan at 1 site in Saudi Arabia.
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 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: looking for participants now, as of the sponsor's last update on 15 Nov 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Mansour Al Shehri, PhD (00966-503946253, moalshehri@jazanu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barthel Index (BI) (time frame: week 0 and week 6). 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 NCT06690073, which also lists 1 linked publication.
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 15 Nov 2024.