HemiplegiaNCT05446207
Effects of Music Therapy Along With Task-Oriented Training on Patients With Chronic Stroke
A study testing Routine Physiotherapy and Task-oriented Training and Music Therapy and Task oriented Training with Routine Physiotherapy in people with Hemiplegia, run by University of Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Routine Physiotherapy and Task-oriented Training and Music Therapy and Task oriented Training with Routine Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2022to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Hemiplegia
- Being tested
- Routine Physiotherapy and Task-oriented Training, Music Therapy and Task oriented Training with Routine Physiotherapy
- Keywords
- Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Physiotherapy and Task-oriented TrainingOther
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.
Music Therapy and Task oriented Training with Routine PhysiotherapyOther
Relaxing Music will be provided through headphones having voice cancellation property for 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music Therapy and Task oriented Training with Routine Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Dynamic and static balance will be measured by Berg Balance Scale
Measured: 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
Measured: Change in functional independence will be measured at baseline, at 4th week, at 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start13 Jun 2022
- Primary completion13 Nov 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Ashfaq Ahmad, PhD, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446207
- Sponsor's protocol ID
- Hafsa Zahid
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immediately after publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05446207
- Acronym / sponsor ID
- Hafsa Zahid
- Conditions
- Hemiplegia
- Keywords
- Stroke, Music Therapy, Task-oriented training, Balance, Functional Independence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 13 Nov 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Routine Physiotherapy and Task-oriented TrainingThis 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. |
| Group B | Experimental | Other: Music Therapy and Task oriented Training with Routine PhysiotherapyThis 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Physiotherapy and Task-oriented TrainingThe 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. | Other | Group A |
| Music Therapy and Task oriented Training with Routine PhysiotherapyRelaxing Music will be provided through headphones having voice cancellation property for 15 minutes. | Other | Group B |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Yes. Immediately after publication
Related trials for Hemiplegia
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
Stroke, Hemiplegia
Active, not recruitingObservational study
Studies of the Variable Phenotypic Presentations of Rapid-Onset Dystonia Parkinsonism and Other Movement Disorders
Dystonia, Parkinsonism
RecruitingObservational study
Post-Stroke Apraxia, Motor Function, Balance, and Gait
Stroke, Ideomotor Apraxia
RecruitingObservational study
Ideomotor Apraxia and Robotic Gait Rehabilitation Outcomes After Stroke
Stroke, Ideomotor Apraxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashfaq Ahmad, PhD study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Physiotherapy and Task-oriented Training and Music Therapy and Task oriented Training with Routine Physiotherapy in people with Hemiplegia, run by University of Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Change in Balance score will be measured at baseline, at 4th week, at 8th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.