- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05446207
Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke
Effects Of Relaxing Music Therapy Along With Task-Oriented Training On Balance And Functional Independence In Patients With Chronic Stroke: A Randomized Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Stroke is a neurological condition, which can promote disability and increase the susceptibility to secondary complications along the patient's life. Stroke issue incorporates motor dysfunction, Cognition, daily activity and sensory weaknesses. Music Therapy appears to affect physiological phenomena such as blood pressure, heartbeat, respiration, and mydriasis as well as emotional aspects such as mood and feelings. Task-oriented training is aimed at improving the control strategy by solving difficulties through various measures.
In general, a variety of techniques, including Bobath approach, Roods approach, Proprioceptive neuromuscular facilitation techniques, motor relearning program, functional approaches, stretching exercises, therapeutic massage, constrain induced movement therapy, range of motion exercises, myofascial release, and strengthening exercises have been in practice for recovery of the affected limb functional mobility in patients with stroke. This study will evaluate the effects of music therapy along with task oriented training on balance and functional independence in stroke patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hafsa Zahid, MS
- Phone Number: +923074597849
- Email: hafsazahid08@gmail.com
Study Contact Backup
- Name: Ayesha Jamil, M.Phil
- Phone Number: +923244481031
- Email: ayeshabutt031@gmail.com
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54000
- The University of Lahore
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age 40-60 years Both males and females Diagnosed stroke patients Chronic stage (after 6 months of onset) Individuals with Burg Balance Score ≥ 20 ≤ 40 Functional Independence Measure score up to 3 (moderate assistance) Able to understand command Mini mental status examination score of over 20
Exclusion Criteria:
Systematic Disorder e.g. Rheumatoid arthritis Unstable Angina Coexisting physical impairments e.g. limb amputation Any previous history of neurological disease other than stroke e.g. Parkinson's Any previous history of fractures Hearing or perception deficits
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: Group A
This group will receive routine physiotherapy with task oriented training.
This protocol will be given for 3 alternative days per week.
Each session will be of 45 minutes.
Data will be collected at baseline, at 4th week and at 8th week.
|
The routine physiotherapy treatment will include TENS and Hot pack.
The task oriented training for lower extremity will include walking training on the ground, equal weight bearing sit-to-stand exercises, resistance exercises e.g.
leg press, leg extension, and leg curl and reaching tasks for improving balance.
There will be a rest period of 5 minutes between each set of training.
|
Experimental: Group B
This group will receive passive music therapy and routine physiotherapy with task oriented training.
This protocol will be given for 3 alternative days per week.
Each session will be of 60 minutes.
Data will be collected at baseline, at 4th week and at 8th week.
|
Relaxing Music will be provided through headphones having voice cancellation property for 15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance
Time Frame: Change in Balance score will be measured at baseline, at 4th week, at 8th week
|
Dynamic and static balance will be measured by Berg Balance Scale
|
Change in Balance score will be measured at baseline, at 4th week, at 8th week
|
Functional Independence
Time Frame: Change in functional independence will be measured at baseline, at 4th week, at 8th week
|
Functional Independence will be measured by Functional Independence Measure
|
Change in functional independence will be measured at baseline, at 4th week, at 8th week
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- Hafsa Zahid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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