StrokeNCT06509646
Comparison of Tai Chi and Frenkel's Exercises in Patients With Stroke
A study testing Tia Chi Exercise and Frenkel's Exercise in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The main objective of this study is to compare the effectiveness of Tai Chi and Frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Tia Chi Exercise and Frenkel's Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2024to 20 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Community-dwelling survivors of stroke who were aged ≥50 years
- Both genders can participate in the study
- ≥3 months poststroke
- The vital signs were stable
- Survivors of both hemorrhagic and ischemic stroke
- Modified Rankin Scale 14 score of three or less
- Short Physical Performance Battery 15 score of 3 to 9
- Mini-Mental State Exam 16,17 score of 18 or greater.
Who cannot join
- The subject is unable to perform exercises.
- Subjects with diagnosed vestibular disease.
- The subjects included in the experiment were normal elderly without stroke diseases.
- The subjects had dyskinesias and could not complete Tai Chi exercises.
- Serious medical condition (e.g. active cancer treatment.
- Stroke survivors whom had no disability that would interfere with study participation.
- Subject taking medications that increases the incidence of fall.
- Subjects who undergoes strength and balance training in the past 3 months.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Alveena fatima
Lahore, Punjab Province, 54660
alveena fatima, m.phill, 03111231810, alveena.fatima@yahoo.com
About this study
Official title: Comparison of Tai Chi and Frenkel's Exercises to Improve Balance, Fall Risk and Activities of Daily Living in Patients With Stroke
The main objective of this study is to compare the effectiveness of Tai Chi and Frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke.
Read the detailed description
A total of 44 patients will be recruited after inclusion and exclusion criteria. Patients will be recruited through nonprobability convenience sampling technique and will be randomized through Lottery method into either a Group A or a Group B, and for each group, the number of patients will be identical. Group A will receive Tai Chi exercises for 1-hour class, 3 times per week for 12 weeks along with routine physical therapy. Routine treatment includes range of motion (ROM) exercise, stretching \& strengthening exercises, passive movements \& gait training. Group A will receive the Tai Chi exercise with conventional treatment and Group B will receive Frenkel's exercise with conventional treatment. Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks. Patients will be assessed at baseline and after the treatment using a variety of measurement scales. After the completion of this time period, the assessment of balance, activities of daily living and fall risk will be performed again and will be compared to baseline assessment to check the comparison between 2 interventions. The risk fall will be measured by Stratify Risk Assessment Tool, Activities of daily will be measured by The Barthel Index (BI) , while balance will be assessed by using berg balance scale (BBC). Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.
- Conditions
- Stroke
- Being tested
- Tia Chi Exercise, Frenkel's Exercise
- Keywords
- Tai Chi Exercise, Frenkel's Exercise, Stroke, ADL, Fall Risk, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tia Chi ExerciseOther
- Yang style 24-posture short-form (16) for 30 minute It consists of 24 unique movements that are performed in a sequence. The form is designed to be easy to learn and can be completed in about six minutes.
Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks
Frenkel's ExerciseOther
Frenkel's exercises 30 minutes (Through these exercises, the patients would learn how to stay balanced and prevent falls by using their visual, somatosensory, and vestibular systems).
Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Goup A (Tia Chi Exercise) | Experimental | * Warm up 5 minutes
* Routine Physical Therapy 20 minutes (which may include exercises such as stretching, strengthening, and range-of- motion exercises)
* Rest Interval 5 minute
* Yang style 24-posture short-form (16) for 30 minute Intensity: low Frequency: 1-2 times/week. Duration: ≤30 min (minutes)(18)
* Cool down 5 mins. Receives: Other: Tia Chi Exercise |
| Group B (Frenkel's Exercise ) | Active comparator | * Warm up 5 minutes
* Routine Physical Therapy 20 minutes (which may include exercises such as stretching, strengthening, and range-of- motion exercises)
* Rest Interval 5 minute
* Frenkel's exercises 30 minutes (Through these exercises, the patients would learn how to stay balanced and prevent falls by using their visual, somatosensory, and vestibular systems) 4. Rest interval 5 minutes 5. Intensity: low 6. Frequency: 1-2 times/week. 7. Duration: ≤30 min (minutes) 8. Cool down 5 mins Receives: Other: Frenkel's Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Barthel Index
The scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent. The for the ten items are summed and x 5 to get a total score out of 100. Proposed guidelines for interpreting Barthel scores are as follows: scores of 0-20 indicate "total" dependency.
Measured: 12th week
The Berg Balance Scale (BBS)
The Berg Balance Score (BBS) is the best-known balance measurement tool, originally designed to measure balance in older individuals. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk)
Measured: 12th week
Fall Risk Assessment Tool (SRATIFY)
The STRATIFY Scale is a tool used to identify risk factors for falls in hospitalized patients, using a 0-5 score to predict patients who will fall. It consists of five questions that assess the patient's history of falls, agitation, visual impairment, toileting needs, and mobility. The total score may be used to predict future falls, but it is more important to identify risk factors using the scale and then plan care to address those risk factors. The tool has good test-retest reliability and moderate inter-rater reliability
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Feb 2024
- Primary completion12 Jul 2024 (estimated)
- Study completion20 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509646
- Sponsor's protocol ID
- REC/RCR&AHS/23/0285 Faraha
- Status last verified
- Jul 2024
- First submitted
- 15 Jul 2024
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tai Chi and Frenkel's Exercises to Improve Balance, Fall Risk and Activities of Daily Living in Patients With Stroke
- ClinicalTrials.gov ID
- NCT06509646
- Acronym / sponsor ID
- REC/RCR&AHS/23/0285 Faraha
- Conditions
- Stroke
- Keywords
- Tai Chi Exercise, Frenkel's Exercise, Stroke, ADL, Fall Risk, Balance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 12 Jul 2024 (estimated)
- Study completion
- 20 Jul 2024 (estimated)
- First posted
- 19 Jul 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.
The main objective of this study is to compare the effectiveness of Tai Chi and Frenkel's exercises to improve balance, fall risk and activities of daily living in patients with stroke.
Detailed description
A total of 44 patients will be recruited after inclusion and exclusion criteria. Patients will be recruited through nonprobability convenience sampling technique and will be randomized through Lottery method into either a Group A or a Group B, and for each group, the number of patients will be identical. Group A will receive Tai Chi exercises for 1-hour class, 3 times per week for 12 weeks along with routine physical therapy. Routine treatment includes range of motion (ROM) exercise, stretching \& strengthening exercises, passive movements \& gait training. Group A will receive the Tai Chi exercise with conventional treatment and Group B will receive Frenkel's exercise with conventional treatment. Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks. Patients will be assessed at baseline and after the treatment using a variety of measurement scales. After the completion of this time period, the assessment of balance, activities of daily living and fall risk will be performed again and will be compared to baseline assessment to check the comparison between 2 interventions. The risk fall will be measured by Stratify Risk Assessment Tool, Activities of daily will be measured by The Barthel Index (BI) , while balance will be assessed by using berg balance scale (BBC). Data will be analyzed by using SPSS (Statistical Package for Social Sciences) 23 version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goup A (Tia Chi Exercise) | Experimental | Other: Tia Chi Exercise* Warm up 5 minutes * Routine Physical Therapy 20 minutes (which may include exercises such as stretching, strengthening, and range-of- motion exercises) * Rest Interval 5 minute * Yang style 24-posture short-form (16) for 30 minute Intensity: low Frequency: 1-2 times/week. Duration: ≤30 min (minutes)(18) * Cool down 5 mins. |
| Group B (Frenkel's Exercise ) | Active comparator | Other: Frenkel's Exercise* Warm up 5 minutes * Routine Physical Therapy 20 minutes (which may include exercises such as stretching, strengthening, and range-of- motion exercises) * Rest Interval 5 minute * Frenkel's exercises 30 minutes (Through these exercises, the patients would learn how to stay balanced and prevent falls by using their visual, somatosensory, and vestibular systems) 4. Rest interval 5 minutes 5. Intensity: low 6. Frequency: 1-2 times/week. 7. Duration: ≤30 min (minutes) 8. Cool down 5 mins |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Community-dwelling survivors of stroke who were aged ≥50 years
- Both genders can participate in the study
- ≥3 months poststroke
- The vital signs were stable
- Survivors of both hemorrhagic and ischemic stroke
Key exclusion criteria (8 listed)
- The subject is unable to perform exercises.
- Subjects with diagnosed vestibular disease.
- The subjects included in the experiment were normal elderly without stroke diseases.
- The subjects had dyskinesias and could not complete Tai Chi exercises.
- Serious medical condition (e.g. active cancer treatment.
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 |
|---|---|---|
| Tia Chi Exercise• Yang style 24-posture short-form (16) for 30 minute It consists of 24 unique movements that are performed in a sequence. The form is designed to be easy to learn and can be completed in about six minutes. Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks | Other | Goup A (Tia Chi Exercise) |
| Frenkel's ExerciseFrenkel's exercises 30 minutes (Through these exercises, the patients would learn how to stay balanced and prevent falls by using their visual, somatosensory, and vestibular systems). Treatment dosage will be 1 session per day of 1 hour class, 2 sets per session, and 5 repetitions per set, 3 times per week and for 12 weeks | Other | Group B (Frenkel's Exercise ) |
Primary outcome
The Barthel Index
Time frame: 12th week
The scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent. The for the ten items are summed and x 5 to get a total score out of 100. Proposed guidelines for interpreting Barthel scores are as follows: scores of 0-20 indicate "total" dependency.
The Berg Balance Scale (BBS)
Time frame: 12th week
The Berg Balance Score (BBS) is the best-known balance measurement tool, originally designed to measure balance in older individuals. It consists of 14 items scored on an ordinal scale of 0 to 4 for a total of 56 points (a higher score indicates lower fall risk)
Fall Risk Assessment Tool (SRATIFY)
Time frame: 12th week
The STRATIFY Scale is a tool used to identify risk factors for falls in hospitalized patients, using a 0-5 score to predict patients who will fall. It consists of five questions that assess the patient's history of falls, agitation, visual impairment, toileting needs, and mobility. The total score may be used to predict future falls, but it is more important to identify risk factors using the scale and then plan care to address those risk factors. The tool has good test-retest reliability and moderate inter-rater reliability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- 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.
Aruba Saeed, phd 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 Tia Chi Exercise and Frenkel's Exercise 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 8 inclusion and 8 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 19 Jul 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, imranamjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Barthel Index (time frame: 12th week). 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?
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 19 Jul 2024.