Clinical trial NCT06658262: Effects of Tai Chi Exercises With Cycling in Subacute Stroke
Official title: Effects Of Tai Chi Exercises With Cycling Exercises On Balance, Gait And Quality Of Life In Sub-Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: CVA,
Tai Chi
Stroke
Rehabilitation
Gait Parameters
Cycling
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 6 weeks
measure: Berg Balance Scale
timeFrame: 6 Weeks
measure: Stroke Specific Quality Of Life (SS-QOL):
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ittefaq Hospital Lahore.
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Asrar Yousaf, Mphil
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.