Effects of Tai Chi Exercises With Cycling in Subacute Stroke

October 24, 2024 updated by: Riphah International University

Effects Of Tai Chi Exercises With Cycling Exercises On Balance, Gait And Quality Of Life In Sub-Acute Stroke Patients

Stroke, a debilitating cerebrovascular event, frequently leads to severe motor and sensory impairments resulting in a diminished quality of life. Tai Chi, an ancient Chinese martial art known for its slow, flowing movements, emphasis on breath control, and mindfulness, presents an intriguing avenue for stroke rehabilitation. While cycling exercises facilitates muscle control of the lower limbs, which may allow putting more weight on the affected leg while standing, also beneficial for stroke survivors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is two-arm parallel design randomized controlled trial. Participants will be selected by non-probability consecutive sampling technique, fifty stroke patients meeting the inclusion criteria will be randomly allocated into two groups (experimental and control) by online randomizer tool. The experimental group will receive tai chi exercises with cycling exercises and the control group will receive tai chi exercises alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. The following primary and secondary assessment tools will be used, Functional Reach Test and Berg Balance scale for balance, Dynamic Gait Index and Wisconsin Gait Scale for gait assessment and Stroke Specific Quality of life (SS-QOL). The data will be analyzed using SPPS software version. 26.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Ittefaq Hospital Lahore.
        • Principal Investigator:
          • Ayesha Khadam, MS-NMPT*

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants with the age ranged between 50-65 years.
  • Participants with either gender.
  • Patients who are in the sub-acute phase (from 2 weeks to less than 3 months after onset).
  • No visual field defect.
  • No abnormality of the vestibular organs.
  • No orthopedic disease.
  • The ability to understand and perform the exercise as instructed by the researcher
  • Muscle power of at least grade three.
  • Could walk at least 10 meters with or without assistive devices.

Exclusion Criteria:

  • Chronic stroke patient.
  • Participants with aphasia and cognitive impairment.
  • Cardiac arrhythmias
  • Any condition for which exercise is contraindicated
  • Fracture of the lower limb.
  • Participants who are currently participating in another clinical trial or research study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Tai Chi Exercises + Cycling exercises. Treatment session of 60 min will be given 3 times a week for 6 weeks.
Other: Tai Chi Exercises With Cycling Exercises
Tai Chai exercises include Ward Off: This movement involves extending and redirecting energy, promoting stability and balance through controlled shifts in weight and posture. Grasp Sparrow's Tail: It comprises a series of movements that emphasize weight shifting, coordination, and maintaining a stable stance, all of which contribute to improved balance and gait. 3.Single Whip: This movement focuses on shifting weight smoothly from one foot to the other while maintaining proper alignment, helping to enhance proprioception and stability. 4.Brush Knee and Twist Step: By incorporating controlled twists and steps, this movement helps to improve coordination, strengthen leg muscles, and refine gait dynamics. Participants will be assisted to safely mount the ergometer bicycle. The height of the seat will be adjusted to ensure postural balance, upright seating and firm contact of the feet with the pedals. Treatment for the cycling will last for 30 minutes per session.
Other: Control Group
Tai Chi Exercises Alone. Treatment session of 60 min will be given 3 times a week for 6 weeks.
Other: Tai Chi Exercises Alone
Tai Chai exercises include Ward Off: This movement involves extending and redirecting energy, promoting stability and balance through controlled shifts in weight and posture. Grasp Sparrow's Tail: It comprises a series of movements that emphasize weight shifting, coordination, and maintaining a stable stance, all of which contribute to improved balance and gait. 3.Single Whip: This movement focuses on shifting weight smoothly from one foot to the other while maintaining proper alignment, helping to enhance proprioception and stability. 4.Brush Knee and Twist Step: By incorporating controlled twists and steps, this movement helps to improve coordination, strengthen leg muscles, and refine gait dynamics. 5.Part the Wild Horse's Mane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Gait Index
Time Frame: 6 weeks
The DGI is developed to assess the likelihood of falling in older adults. It is designed to test eight facets of gait. Equipment needed: Box (Shoebox), Cones (2), Stairs, 20' walkway, 15" wide. Completion time is 15 minutes. A four-point ordinal scale, ranging from 0-3 is used for scoring. "0" indicates the lowest level of function and "3" the highest level of function. Total Score = 24. The ICC2 for intra-rater and inter-rater reliability of total DGI scores is 0.86 and 0.91 respectively.
6 weeks
Berg Balance Scale
Time Frame: 6 Weeks
Balance will be measured using the Berg Balance Scale (BBS).The BBS is a 14-item scale that quantitatively assesses balance through direct observations of the performance ability, with each item scored from 0 ('inability to complete the task') to 4 ('independent completion'). The total possible score is 56 points, with higher scores indicating that the person has better balance. The berg balance scale reliability is 0.98, validity: r=0.91
6 Weeks
Stroke Specific Quality Of Life (SS-QOL):
Time Frame: 6 weeks
The perceived QOL will be measured using the Korean version of the Stroke-Specific Quality of Life questionnaire (SS-QOL), which evaluates the level of energy, family roles, language, mobility, mood, social roles, personality, thinking, and self-care using a 5-point Likert scale. The validity of psychometrics measures of the original version of the scale was reported, with a reliability coefficient of 0.73-0.89. Cronbach's values for the subscales of the SS-QOL were 0.92-0.93 among stroke survivors.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Muhammad Asrar Yousaf, Mphil, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 24, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

February 3, 2025

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/24/0209

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

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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