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

Stroke Clinical Trial

Official title:

Comparison of Modified-Otago and Tai Chi Exercises on Balance and Motor Function in Patients With Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06308224
• Other study ID #: REC/RCR&AHS/23/0290
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2024
• Est. completion date: May 24, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: Muhammad Kashif, PhD-PT
• Phone: 03333125303
• Email: kahif.shaffi[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: May 24, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Riphah International University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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