- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07332897
Motor Relearning Program Combined With Neck Stabilization Exercises in Subacute Stroke
Study Overview
Status
Conditions
Detailed Description
This is a randomized clinical trial. Target population is patients suffering from subacute stroke with an MMSE score of 24 and above. Data will be collected from The University of Lahore teaching Hospital and Shadman Medical Center. This study will include 96 participants with 10% dropout ratio, according to the selection criteria. The participants will be randomly divided into two groups through a computer-generated random number table.
Group A will recruit 48 patients to fulfil the inclusion criteria. These patients will undergo a 60 minutes session delivered for four weeks with 5 sessions every week, including warm-up, neck stabilization exercises, cranio-cervical flexion, cervical isometrics, 3 sets x 10 repetitions each 10 seconds hold, eye head coordination drills, 3 sets 60 seconds, focusing on target (right, left, up, down) neck control while reaching, 10 successful attempts, all performed in assisted sitting position. Combined with motor relearning program activities assisted supported sitting & standing grasping and releasing cylinder progressing to cloth, reaching targets forward and sideways, picking objects and transferring over shelves 2 meters apart, Coin stacking, assisted grooming and ADLs (combing hair, turning keys, drinking water) 10 successful attempts of each activity. Group B will recruit 48 patients which fulfill the inclusion criteria. These patients will be treated by routine physical therapy, evidence-based exercises including AAROM of shoulder, elbow & wrist joint, Scapular retraction, Shoulder and elbow isometrics, stretching of pectoralis minor and shoulder internal rotators, therapist assisted PNF diagonals for upper limb (Three sets of 10 repetitions each, squeeze hold for 10 seconds, stretch hold for 30 seconds and motor relearning program activities same as Group A, delivered under supervision over a timeframe of 60 minutes per session for four weeks, 5 times per week. The Statistical analysis will be performed through SPSS Software 21
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Shadman Medical Center
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Lahore, Punjab Province, Pakistan, 54000
- The University of Lahore Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed for stroke in subacute phase by a neurologist
- Patients with Mini Mental State Examination score of 24 and above
Exclusion Criteria:
- Patients with accompanying mental Disorders (unable to cooperate)
- Fracture of upper limb in last 6 months
- Recent surgery of upper periphery effecting mobility and motor functionality
- Non consenting to intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: nterventional Group A
Experimental: Interventional Group A These patients will be treated by neck stabilization exercises and motor relearning program with 3 sets of 10 repetitions each and 10 seconds along with 10 successful attempts in one session. Delivered five times a week for four weeks For this, participants will be given a comfortable assisted sitting and transition to standing position. |
Neck stabilization exercises and Motor relearning program based functional activities will be performed
|
|
Active Comparator: Interventional Group B
Active Comparator: Interventional Group B These patients will be treated by routine physical therapy exercises with motor relearning program with three sets of 10 repetitions each, squeeze hold for 10 seconds, stretch hold for 30 seconds repetitions in one session for 4 weeks, five times every week. For this, participants will be given a comfortable supine lying transition to assisted sitting position. |
Routine Physical therapy exercises and Motor relearning program based functional activities will be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensorimotor Function
Time Frame: Four weeks
|
Sensorimotor function will be assessed by using Urdu translated version of Fugl-Meyer Assessment (FMA) for Upper Extremity (UE)
|
Four weeks
|
|
Upper Limb Functionality
Time Frame: Four weeks
|
Functionality, assessed by using Wolf Motor Functional Test
|
Four weeks
|
|
Health Related Quality of Life
Time Frame: Four weeks
|
Health Related Quality of life will be assessed by using Stroke Impact Scale
|
Four weeks
|
Collaborators and Investigators
Sponsor
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 (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB
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
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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