Comparison of Modified-Otago and Tai Chi Exercises in Patients With Stroke

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Modified-Otago Exercises; Other: Tai-Chi Exercises

• Registration Number: NCT06308224
• Lead Sponsor: Riphah International University

Brief Summary

The study aims to determine the comparative effects of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients with Stroke.

Detailed Description

This randomized clinical trial will be conducted at the Physiotherapy and Chiropractor Centre, Lahore. Data will be collected within seven months after the approval of synopsis. A total of 64 patients will be recruited through convenience sampling technique after inclusion and exclusion criteria. After the baseline assessment, randomizations will be performed through the lottery method. Group A will receive Modified Otago exercises for 60 minutes, 3 times per week for 12 weeks, and Group B will receive Tai Chi Qigong exercises for 60 minutes, 3 times per week for 12 weeks. To assess the balance and motor function, the Berg Balance Scale (BBS) and Motor Assessment Scale will be used, respectively. The data will be analyzed by using the SPSS (Statistical Package for Social Sciences) 23 version.

Study Timeline

• Study Start: 2024-02-25
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-13
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-10
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Clinically diagnosed stroke patients with ischemic type.
2. Post-stroke ≥ 3 months.
3. Survivors of both hemorrhagic and ischemic stroke.
4. Subjects should have stable conditions after the stroke incidence.
5. Community-dwelling survivors of stroke who were aged ≥40 years.
6. Both genders can participate in the study.
7. Mini-Mental State Exam score equal to or greater than 24.
8. Modified Rankin Scale score of three or less.
9. Berg Balance Scale score is between 41 and 52.
10. Muscle strength grade should be of grade 4 and above.

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Exclusion Criteria

1. Subjects with diagnosed peripheral neuropathy.
2. The subject is unable to perform Tai Chi exercises.
3. No history of other neurological and musculoskeletal conditions.
4. Subjects with diagnosed vestibular disease.
5. Subjects have cardiac abnormalities.
6. Contracture, fracture, or pain in the musculoskeletal system.
7. Subjects who have undergone strength and balance training in the past 3 months.
8. Subject taking medications that increase the incidence of falls.
9. Subjects have been diagnosed with malignancy of any type.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Modified-Otago Exercises)	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. 1. Walking for 15 minutes 2. Strengthening exercises for 10 minutes 3. Balance exercises 20 minutes
Group B (Tai Chi Exercises)	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. 1. Warm-up exercises for 10 minutes 2. Tai Chi Exercises for 30 minutes 3. Cool-down exercises for 5 minutes

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	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).
Timed Up and Go (TUG)	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.
Motor Assessment Scale (MAS)	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.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Lahore, Punjab, Pakistan