- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06509646
Comparison of Tai Chi and Frenkel's Exercises in Patients With Stroke
Comparison of Tai Chi and Frenkel's Exercises to Improve Balance, Fall Risk and Activities of Daily Living in Patients With Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imranamjad@riphah.edu.pk
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54660
- Recruiting
- Alveena fatima
-
Contact:
- alveena fatima, m.phill
- Phone Number: 03111231810
- Email: alveena.fatima@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Goup A (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 |
|
Active Comparator: Group B (Frenkel's Exercise )
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12th week
|
|
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)
|
12th week
|
|
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
|
12th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, PhD, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0285 Faraha
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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