- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06690073
The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation. (MRP)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohammed Mansour Al Shehri, PhD
- Phone Number: 00966-503946253
- Email: moalshehri@jazanu.edu.sa
Study Locations
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-
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Riyadh, Saudi Arabia
- Recruiting
- King Saud Medical City
-
Contact:
- Khadijah Abdulrahman Alfaleh, MPT
- Phone Number: 00966543997595
- Email: khadooj1411@hotmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria: The following subjects were included:
- 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.
Exclusion criteria: The following subjects were excluded:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
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.
|
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.
|
|
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 |
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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week 0 and week 6
|
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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).
|
week 0 and week 6
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Apr.13/COM-2022/32-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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