HemiplegiaNCT06457516
Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Training in Post Stroke Hemiplegic Patients
A study testing Mirror Therapy and Music Therapy in people with Hemiplegia, run by Superior University at 1 site in Pakistan.
Trial summary
A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Hemiplegia
- What is being tested?
- Mirror Therapy and Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 1 Feb 2023
- 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
- ischemic and hemorrhagic post stroke hemiplegic patients
- patients of age 40-60 years
- no visual perception dysfunction
Who cannot join
- patients with fracture of upper or lower limb
- patient with comorbidities
- patients with hearing issues
- patients with cognitive disabilities
- patient with other neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Balance and Gait Training in Post Stroke Hemiplegic Patients: Randomized Control Trial
A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).
Read the detailed description
It was a single-blinded study. Mirror therapy was given to group A and music therapy was given to group B. Our findings support the alternate hypothesis. This indicates the small effect size for BBS in group A and the moderate effect size for the gait assessment scale in favor of group A.
- Conditions
- Hemiplegia
- Being tested
- Mirror Therapy, Music Therapy
- Medical subject headings
- Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror TherapyCombination product
A mirror is used to create a reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain, or to create positive visual feedback of a limb movement. It involves placing the affected limb behind a mirror.
Music TherapyOther
Music therapy, an allied health profession, the clinical and evidence-based use of music interventions to accomplish individualized goals
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy | Experimental | Not described Receives: Combination Product: Mirror Therapy |
| Music Therapy | Other | Not described Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BBS (berg balance scale)
A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke.
Measured: 6 Month
FGA (functional gait assessment scale)
The normal score on the FGA would be considered >27/30; for adults from ages 60 to 80 years, the normal score on the FGA would be considered >24/30; and for adults over the age of 80 years, the normal score would be considered >19/30
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2022
- Study completion1 Feb 2023
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 Superior UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457516
- Sponsor's protocol ID
- DPT/Batch-Fall18/550
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effectiveness of Mirror Therapy VS Music Therapy for Balance and Gait Training in Post Stroke Hemiplegic Patients: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06457516
- Acronym / sponsor ID
- DPT/Batch-Fall18/550
- Conditions
- Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 13 Jun 2024 (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.
A randomized clinical trial was performed on hemiplegic post-stroke patients with a sample size of 50 (25 in each group).
Detailed description
It was a single-blinded study. Mirror therapy was given to group A and music therapy was given to group B. Our findings support the alternate hypothesis. This indicates the small effect size for BBS in group A and the moderate effect size for the gait assessment scale in favor of group A.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy | Experimental | Combination Product: Mirror Therapy |
| Music Therapy | Other | Other: Music Therapy |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ischemic and hemorrhagic post stroke hemiplegic patients
- patients of age 40-60 years
- no visual perception dysfunction
Key exclusion criteria (5 listed)
- patients with fracture of upper or lower limb
- patient with comorbidities
- patients with hearing issues
- patients with cognitive disabilities
- patient with other neurological disease
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 |
|---|---|---|
| Mirror TherapyA mirror is used to create a reflective illusion of an affected limb in order to trick the brain into thinking movement has occurred without pain, or to create positive visual feedback of a limb movement. It involves placing the affected limb behind a mirror. | Combination product | Mirror Therapy |
| Music TherapyMusic therapy, an allied health profession, the clinical and evidence-based use of music interventions to accomplish individualized goals | Other | Music Therapy |
Primary outcome
BBS (berg balance scale)
Time frame: 6 Month
A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling. A score of ≤49 indicates a risk of falls in individuals with stroke.
FGA (functional gait assessment scale)
Time frame: 6 Months
The normal score on the FGA would be considered >27/30; for adults from ages 60 to 80 years, the normal score on the FGA would be considered >24/30; and for adults over the age of 80 years, the normal score would be considered >19/30
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 13 Jun 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mirror Therapy and Music Therapy in people with Hemiplegia, run by Superior University 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 3 inclusion and 5 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 13 Jun 2024. 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?
BBS (berg balance scale) (time frame: 6 Month). 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 13 Jun 2024.