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Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke

Primary Purpose

Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Routine Physiotherapy and Task-oriented Training
Music Therapy and Task oriented Training with Routine Physiotherapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Balance
Dynamic and static balance will be measured by Berg Balance Scale
Functional Independence
Functional Independence will be measured by Functional Independence Measure

Secondary Outcome Measures

Full Information

First Posted
July 1, 2022
Last Updated
April 5, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05446207
Brief Title
Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
November 13, 2022 (Actual)
Study Completion Date
December 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Previous studies discussed the effects of music therapy and task oriented training on motor functions of stroke separately but no study is found in which effects of both techniques are studied. In this study, we are going to find the effects of task oriented training with or without music therapy.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia
Keywords
Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
It will be single blinded study in which the outcome assessor will be unaware of the treatment intervention.
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Routine Physiotherapy and Task-oriented Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Music Therapy and Task oriented Training with Routine Physiotherapy
Intervention Description
Relaxing Music will be provided through headphones having voice cancellation property for 15 minutes.
Primary Outcome Measure Information:
Title
Balance
Description
Dynamic and static balance will be measured by Berg Balance Scale
Time Frame
Change in Balance score will be measured at baseline, at 4th week, at 8th week
Title
Functional Independence
Description
Functional Independence will be measured by Functional Independence Measure
Time Frame
Change in functional independence will be measured at baseline, at 4th week, at 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashfaq Ahmad, PhD
Organizational Affiliation
The University of Lahore
Official's Role
Study Director
Facility Information:
Facility Name
The University of Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Immediately after publication
IPD Sharing Time Frame
Beginning 9 months and ending on 36th month

Learn more about this trial

Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke

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