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

NCT06308224 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0290
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Modified-Otago Exercises; Tai-Chi Exercises; Stroke; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (3)

• Berg Balance Scale (BBS)

  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).

  12 weeks

• Timed Up and Go (TUG)

  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.

  12 weeks

• Motor Assessment Scale (MAS)

  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.

  12 weeks

Study Arms (2)

Group A (Modified-Otago Exercises)

EXPERIMENTAL

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

Other: Modified-Otago Exercises

Group B (Tai Chi Exercises)

EXPERIMENTAL

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

Other: Tai-Chi Exercises

Interventions

Modified-Otago Exercises OTHER

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.

Also known as: Rehabilitation

Group A (Modified-Otago Exercises)

Tai-Chi Exercises OTHER

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.

Also known as: Rehabilitation

Group B (Tai Chi Exercises)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Muhammad Kashif, PhD-PT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single-blinded as the assessor of the study would be kept blind of the treatment groups to which the patient would be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 13, 2024
• Study Start: February 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)