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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Modified-Otago Exercises; Other: Tai-Chi Exercises

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 Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54660
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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; Strengthening exercises for 10 minutes; Balance exercises 20 minutes	Other: Modified-Otago Exercises; 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: Rehabilitation
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.; Warm-up exercises for 10 minutes; Tai Chi Exercises for 30 minutes; Cool-down exercises for 5 minutes	Other: Tai-Chi Exercises; 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: Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Study Chair: Muhammad Kashif, PhD-PT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2024
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Stroke; Randomized Clinical Trial; Modified-Otago Exercises; Tai-Chi Exercises
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: REC/RCR&AHS/23/0290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No