StrokeNCT06658262
Effects of Tai Chi Exercises With Cycling in Subacute Stroke
A study testing Tai Chi Exercises With Cycling Exercises and Tai Chi Exercises Alone in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Tai Chi Exercises With Cycling Exercises and Tai Chi Exercises Alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Oct 2024to 3 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ittefaq Hospital Lahore.
Lahore, Punjab Province
Ayesha Khadam, MS-NMPT*
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Tai Chi Exercises With Cycling Exercises, Tai Chi Exercises Alone
- Keywords
- CVA,, Tai Chi, Stroke, Rehabilitation, Gait Parameters, Cycling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi Exercises With Cycling ExercisesOther
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 AloneOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Tai Chi Exercises + Cycling exercises. Treatment session of 60 min will be given 3 times a week for 6 weeks. Receives: 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. Receives: Other: Tai Chi Exercises Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start24 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion3 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, Mphil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658262
- Sponsor's protocol ID
- REC/RCR & AHS/24/0209
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34006551Hsu 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.
PubMed 26860794Thant 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.
PubMed 30774211Batool 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.
PubMed 37330797Perez-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.
PubMed 33430476
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Tai Chi Exercises With Cycling Exercises On Balance, Gait And Quality Of Life In Sub-Acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06658262
- Acronym / sponsor ID
- REC/RCR & AHS/24/0209
- Conditions
- Stroke
- Keywords
- CVA,, Tai Chi, Stroke, Rehabilitation, Gait Parameters, Cycling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 3 Feb 2025 (estimated)
- First posted
- 26 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Tai Chi Exercises With Cycling ExercisesTai Chi Exercises + Cycling exercises. Treatment session of 60 min will be given 3 times a week for 6 weeks. |
| Control Group | Other | Other: Tai Chi Exercises AloneTai Chi Exercises Alone. Treatment session of 60 min will be given 3 times a week for 6 weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (6 listed)
- Chronic stroke patient.
- Participants with aphasia and cognitive impairment.
- Cardiac arrhythmias
- Any condition for which exercise is contraindicated
- Fracture of the lower limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi Exercises With Cycling ExercisesTai 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 | Experimental Group |
| Tai Chi Exercises AloneTai 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 | Other | Control Group |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 34006551Jing 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.
- Background: PubMed 26860794Hsu 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.
- Background: PubMed 30774211Thant 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.
- Background: PubMed 37330797Batool 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.
- Background: PubMed 33430476Perez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Asrar Yousaf, Mphil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Exercises With Cycling Exercises and Tai Chi Exercises Alone in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658262, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.