NCT05446207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

July 1, 2022

Last Update Submit

April 5, 2023

Conditions

Keywords

Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence

Outcome Measures

Primary Outcomes (2)

  • Balance

    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

    Functional Independence will be measured by Functional Independence Measure

    Change in functional independence will be measured at baseline, at 4th week, at 8th week

Study Arms (2)

Group A

ACTIVE COMPARATOR

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.

Other: Routine Physiotherapy and Task-oriented Training

Group B

EXPERIMENTAL

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.

Other: Music Therapy and Task oriented Training with Routine Physiotherapy

Interventions

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.

Group A

Relaxing Music will be provided through headphones having voice cancellation property for 15 minutes.

Group B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

HemiplegiaStroke

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ashfaq Ahmad, PhD

    University of Lahore

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It will be single blinded study in which the outcome assessor will be unaware of the treatment intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ayesha Jamil

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

June 13, 2022

Primary Completion

November 13, 2022

Study Completion

December 13, 2022

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

Immediately after publication

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 9 months and ending on 36th month

Locations