- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06308224
Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke
Comparison of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
- Email: kahif.shaffi@riphah.edu.pk
Study Contact Backup
- Name: Shamsa Tariq, MSPT
- Phone Number: 03068189981
- Email: shamsa.dpt5@gmail.com
Study Locations
-
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Punjab
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Lahore, Punjab, Pakistan, 54660
- Recruiting
- Riphah International University
-
Contact:
- Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
- Email: kahif.shaffi@riphah.edu.pk
-
Contact:
- Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Clinically diagnosed stroke patients with ischemic type.
- Post-stroke ≥ 3 months.
- Survivors of both hemorrhagic and ischemic stroke.
- Subjects should have stable conditions after the stroke incidence.
- Community-dwelling survivors of stroke who were aged ≥40 years.
- Both genders can participate in the study.
- Mini-Mental State Exam score equal to or greater than 24.
- Modified Rankin Scale score of three or less.
- Berg Balance Scale score is between 41 and 52.
- Muscle strength grade should be of grade 4 and above.
Exclusion Criteria:
- Subjects with diagnosed peripheral neuropathy.
- The subject is unable to perform Tai Chi exercises.
- No history of other neurological and musculoskeletal conditions.
- Subjects with diagnosed vestibular disease.
- Subjects have cardiac abnormalities.
- Contracture, fracture, or pain in the musculoskeletal system.
- Subjects who have undergone strength and balance training in the past 3 months.
- Subject taking medications that increase the incidence of falls.
- Subjects have been diagnosed with malignancy of any type.
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 |
---|---|
Experimental: Group A (Modified-Otago Exercises)
Participants will engage in Modified-Otago exercises for 30 minutes of moderate-intensity exercise at least three times weekly for 12 weeks.
|
Walking for 15 minutes before or after the strengthening and balance exercises of Modified-Otago. Strengthening exercises for 10 minutes: Knee extensor, Knee flexor, Hip adductor, Ankle plantar flexors (calf raises), and Ankle dorsiflexion (toe raises). Balance exercises 20 minutes: Knee bends, Backwards walking, Walking and turning around, Sideways walking, Tandem stance (heel-toe stand), Tandem walk (heel-toe walk), One leg stand, Heel walking, Toe walk, Heel toe walking backward, sit to stand and Stair walking.
Other Names:
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Experimental: Group B (Tai Chi Exercises)
Participants of the Tai Chi qigong group will participate in a 30-minute exercise class three times a week for 12 weeks.
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Warm-up exercises for 10 minutes. Tai Chi Qigong Exercises for 30 minutes: Commencing form and regulating breathing, Expanding your chest, Painting a rainbow, Circling arms to separate the clouds, Fixed step invert brachial, Row a boat in the middle of the lake, Shoulder the ball, Turning the body to look at the moon, Twisting waist and pushing palms, Horse step and cloud hands, Drag the sea and watch the sky, Undulating waves, Dove spreading wings, Extend arms and punch, Wild goose flying, Flywheel turning, Bounce ball while stepping, Pressing palms in calmness. Cool-down exercises for 5 minutes.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg Balance Scale (BBS)
Time Frame: 12 weeks
|
The BBS, a 14-item scale, quantitatively evaluates balance and fall risk in older community-dwelling adults by directly observing their performance.
Scores range from 0 to 4, with 0 indicating inability and 4 representing independent completion.
The total score, out of 56, categorizes balance as impaired (0-20), acceptable (21-40), or good (41-56).
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12 weeks
|
Timed Up and Go (TUG)
Time Frame: 12 weeks
|
The Timed Up and Go (TUG) is a comprehensive physical performance test designed to evaluate mobility, balance, and locomotor abilities in elderly individuals dealing with balance issues.
The test involves a sequence of motor tasks related to walking and turning.
Without specific items, the individual is required to stand up from a chair (not leaned against a wall), walk 3 meters, turn around, return to the chair, and sit down at a comfortable pace.
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12 weeks
|
Motor Assessment Scale (MAS)
Time Frame: 12 weeks
|
The Motor Assessment Scale (MAS) serves as a performance-based evaluation tool designed to assess everyday motor function in stroke patients.
It encompasses 8 items representing different areas of motor function.
A single item assesses the general tonus to estimate muscle tone on the affected side.
Ratings, scored on a 7-point scale (0-6), indicate optimal motor behavior, with a sum of item scores (excluding general tonus) providing an overall score out of 48 points.
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12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Muhammad Kashif, PhD-PT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- REC/RCR&AHS/23/0290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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