NCT06658262

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2025

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

CVA,Tai ChiStrokeRehabilitationGait ParametersCycling

Outcome Measures

Primary Outcomes (3)

  • Dynamic Gait Index

    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

    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):

    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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

OTHER

Tai Chi Exercises Alone. Treatment session of 60 min will be given 3 times a week for 6 weeks.

Other: Tai Chi Exercises Alone

Interventions

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.

Experimental Group

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

Control Group

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ittefaq Hospital Lahore.

Lahore, Punjab Province, Pakistan

Location

Related Publications (5)

  • Jing C, Li K, Li Z, Sun Y, Wu J, Li Y, Li Y, Zhou L, Zhang Z, Zhao M, Zhang Y. Tai Chi postural training for dyskinesia rehabilitation: a study protocol for a randomised controlled trial in convalescent ischaemic stroke patients. BMJ Open. 2021 May 18;11(5):e046003. doi: 10.1136/bmjopen-2020-046003.

    PMID: 34006551BACKGROUND
  • Hsu CY, Moyle W, Cooke M, Jones C. Seated Tai Chi versus usual activities in older people using wheelchairs: A randomized controlled trial. Complement Ther Med. 2016 Feb;24:1-6. doi: 10.1016/j.ctim.2015.11.006. Epub 2015 Dec 2.

    PMID: 26860794BACKGROUND
  • Thant AA, Wanpen S, Nualnetr N, Puntumetakul R, Chatchawan U, Hla KM, Khin MT. Effects of task-oriented training on upper extremity functional performance in patients with sub-acute stroke: a randomized controlled trial. J Phys Ther Sci. 2019 Jan;31(1):82-87. doi: 10.1589/jpts.31.82. Epub 2019 Jan 29.

    PMID: 30774211BACKGROUND
  • Batool S, Zafar H, Gilani SA, Ahmad A, Hanif A. Intrarater and interrater reliability of the dynamic gait index in post stroke patients with eye movement disorders. J Bodyw Mov Ther. 2023 Jul;35:38-42. doi: 10.1016/j.jbmt.2023.04.015. Epub 2023 Apr 14.

    PMID: 37330797BACKGROUND
  • Perez-de la Cruz S. Comparison between Three Therapeutic Options for the Treatment of Balance and Gait in Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jan 7;18(2):426. doi: 10.3390/ijerph18020426.

    PMID: 33430476BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Muhammad Asrar Yousaf, Mphil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

October 24, 2024

Primary Completion

December 30, 2024

Study Completion

February 3, 2025

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations