- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05069480
Modulation of Upper Limb Spasticity Post-Stroke
Interactive Game-Based Rehabilitation for Controlling Upper Limb Spasticity Post Stroke
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mecca, Saudi Arabia, 21955
- Ehab Abd El Kafy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
The inclusion criteria were as follow:
- Participants were diagnosed as chronic stroke patients.
- Participants were selected to be in the spastic phase, 6-24 months following a first stroke.
- The degree of spasticity in the affected upper limbs, was ranged between grades (1, 1+&2) according to Modified Ashworth Scale.
- Participants were all between 50 and 60 years old, of both sexes.
- Participants were cognitively able to understand and follow instructions.
- Participants had the ability to extend their wrist joints at least 20° and fingers 10° from full flexion. This range allowed participants to engage easily in performing a designed functional program.
Exclusion Criteria:
The exclusion criteria were as follow:
- Participants who were with any orthopaedic condition or fixed deformity that interfere with the upper limb functions.
- Participants who were with spasticity more than score 2 according to the Modified Ashworth Scale.
- Participants who had cognitive or perceptual problems.
- Participants with surgical interference for the upper limb and spine within the previous 2 years.
- Participants with seizures, visual impairments, or auditory problems.
- Participants who had shoulder pain on a visual analogue scale of > 6/10.
- Participants who had Botulinum Toxin in the upper extremity musculature six months before baseline assessment.
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 |
---|---|
Active Comparator: Control Group
Participants who participated in the control group received a traditional physical therapy program for two hours. It included two parts, each of them was one hour and few minutes rest in between. The first part included: reflex inhibiting patterns, strengthening activities, stretching exercises, and postural reactions exercises. The second part included: arm-reaching tasks, arm-hand tasks, hand manipulative tasks for the more affected upper limb through performing functional tasks of daily living activities. The traditional intervention was carried out three sessions per week for twelve successive weeks. |
The traditional physical therapy program aimed for inhibition of spasticity, facilitation of muscle action, and improving the motor functions of the involved upper limbs.
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Experimental: Experimental Group
Participants of the experimental group have received two hours treatment program that included three parts, the first and the second parts were similar to that applied for participants in the control group for one hour followed by few minutes rest, then the third part was applied for one hour. The third part included a virtual reality intervention program by using virtual reality equipment to simulate a range of upper limb tasks related to arm-hand activities and hand manipulative tasks through using different games and soft-wares. The treatment program for the experimental group was carried out three sessions per week for twelve successive weeks. |
The traditional physical therapy program aimed for inhibition of spasticity, facilitation of muscle action, and improving the motor functions of the involved upper limbs.
It is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback.
The equipment facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries.
It combines adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the score of The Wolf Motor Function Test (test that assess the change in upper extremity motor ability)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Wolf Motor Function Test Score at both baseline and completion of 12 weeks of intervention)
|
The Wolf Motor Function Test (WMFT) is designed to assess upper extremity motor abilities in patients with stroke through timed and functional tasks.
The WMFT consists of 15 timed items (6 items involve timed functional tasks, and 9 items consist of analyzing movement quality when completing various tasks), in addition to 2 items (7&14) are measures of strength.
The examiner should test the less affected upper extremity followed by the most affected side.
The 15 timed items are rated on a 6-point functional ability scale (0-5), score (0) means the patient is unable to use UE being tested while score (5) means the patient is able to use it and movement appears to be normal.
The total score on the WMFT ranges from 0 to 75.
Lower scores are indicative of lower functioning levels.
Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity (UE) motor abilities.
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[Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Wolf Motor Function Test Score at both baseline and completion of 12 weeks of intervention)
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Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 12 weeks of intervention)
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia.
It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.
The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally.
The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
Thus, the higher the score a patient get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
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[Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 12 weeks of intervention)
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Change in the Modified Ashworth Scale (scale that assess the change in muscle tone)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of muscle tone at both baseline and completion of 12 weeks of intervention)
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Modified Ashworth Scale was used to evaluate the degree of spasticity in the involved upper limb in the elbow and wrist joints.
MAS is a valid and a reliable scale to evaluate the degree of muscle tone for all participants pre and post treatment.
It is scored on a 6 -graded ordinal scale.
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[Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of muscle tone at both baseline and completion of 12 weeks of intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the upper limb' joints range of motion (in degree)
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of upper limb' joints range of motion at both baseline and completion of 12 weeks of intervention)
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Digital Goniometer was used to evaluate the following joints range of motion (Shoulder, Elbow, and Wrist Joints).
The Digital Goniometer has used a sensor to calculate the amount of joint range of motion in degrees to measure the true range of motion value.
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[Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the degree of upper limb' joints range of motion at both baseline and completion of 12 weeks of intervention)
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Change in the Hand Grip Strength of the involved upper extremity (Kg) (which indicate the change of the strength of the involved hand muscles in patients with stroke).
Time Frame: [Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between hand grip strength at both baseline and completion of 12 weeks of intervention)
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Hand Grip Dynamometer was used to assess the change in the strength of the hand muscles of the involved upper extremity.
The higher the score of the hand grip after completion of the treatment program compared to the baseline score, the better the improvement of hand functional abilities.
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[Data was collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between hand grip strength at both baseline and completion of 12 weeks of intervention)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ehab M Abd El Kafy, Ph.D, Professor of Physical Therapy -Umm Al Qura University.
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Paralysis
- Muscle Hypertonia
- Stroke
- Hemiplegia
- Muscle Spasticity
Other Study ID Numbers
- ID MED99-10 -14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
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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