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NCT Number: NCT06658262

Effects of Tai Chi Exercises With Cycling in Subacute Stroke

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.

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Key information

Conditions

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

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ittefaq Hospital Lahore.

Lahore, Punjab Province, Pakistan

Location contact

Ayesha Khadam, MS-NMPT*

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tai Chi Exercises With Cycling Exercises

Other

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.

Tai Chi Exercises Alone

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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