- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06457022
Outcome Measures of Modified Constraint Induced Movement Therapy Versus Dual Task Training on Upper Extremity and Cognitive Functions in Patients With Hemiparesis
July 18, 2024 updated by: Ahmed Alshimy
All stroke patients were assessed via isokinetic dynamometer, Montreal cognitive assessment scale (MOCA) and Fugl Myer Upper extremity (FMUE) before and after the treatment program.
Study Overview
Status
Completed
Conditions
Detailed Description
The patients were classified randomly into three equal groups, Study group A (GA) receiving modified constraint induced movement therapy in addition to conventional physical therapy program, Study group B (GB) receiving dual task training in addition to conventional physical therapy program and control group C (GC) receiving only conventional physiotherapy program.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menoufia
-
Sadat, Menoufia, Egypt
- Al Ryada University for Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with age range between 55 and 65 years old.
- The patients were from both genders (males &females).
- Patients were of duration of illness between 6 and 12 months.
- The patients were scoring 1 &1+ on modified Ashworth scale (mild spasticity).
- The patients were of good ability to see and hear.
- Consent form was obtained from all participants to approve the study and follow the commands.
- All patients were scoring more than 26 on MMSE. All patients were medically stable.
Exclusion Criteria:
- patients with moderate and sever spasticity.
- patients with cognitive disorder due to other cause rather than spasticity.
- patients with unstable medical conditions.
- patients with previous or recurrent stroke.
- patients with respiratory problems.
- patients with shoulder dislocation or subluxation or frozen shoulder.
- patients with uncontrolled hypertension, diabetes mellitus, unstable angina or heart failure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Receiving modified constraint induced movement therapy , for 30 minutes , in addition to conventional physiotherapy program for the other 30 minutes.
|
patient wears a restraint instrument in his unaffected hand, then applying massed practice to his affected upper extremity.
The patient wears padded glove in his unaffected upper extremity for restraining the patient from using his unaffected upper extremity for about 3 hours per day including the treatment session and the home program.
So, by this way the patient is reinforced to use his affected upper extremity during this period of time to achieve his activities of daily living.
Finally, the total time, the patient spends it during the day wearing the glove should be recorded each day.
Ultrasound on shoulder.
Graduated active exercises for shoulder.
Prolonged stretching for spastic muscles
|
|
Experimental: Group B
Receiving dual task training (Cognitive-Motor) for 30 minutes, in addition to conventional physiotherapy program for the other 30 minutes.
|
Ultrasound on shoulder.
Graduated active exercises for shoulder.
Prolonged stretching for spastic muscles
Verbal fluency: Ask the hemiparetic patient to title many words of specific type as fruits, vegetable or animals.
Mental tracking: as the hemiparetic patient to subtract serial 3 between number 90 and 100.
|
|
Other: Group C
Receiving only conventional physiotherapy program for 60 minutes.
|
Ultrasound on shoulder.
Graduated active exercises for shoulder.
Prolonged stretching for spastic muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biodex isokinetic dynamometer
Time Frame: 4 weeks
|
Used to assess muscle strength and function
|
4 weeks
|
|
Montreal cognitive assessment
Time Frame: 4 weeks
|
a quick test that is used to examine mild cognitive impairment and early dementia.
|
4 weeks
|
|
Fugl Myer upper extremity
Time Frame: 4 weeks
|
a scale used to measure the functional impairment of stroke
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 10, 2024
Primary Completion (Actual)
July 5, 2024
Study Completion (Actual)
July 10, 2024
Study Registration Dates
First Submitted
June 8, 2024
First Submitted That Met QC Criteria
June 8, 2024
First Posted (Actual)
June 13, 2024
Study Record Updates
Last Update Posted (Actual)
July 19, 2024
Last Update Submitted That Met QC Criteria
July 18, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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