Comparison of Tai Chi and Frenkel's Exercises in Patients With Stroke

July 18, 2024 updated by: Riphah International University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
  • 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.

• 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 )
  • 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

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Aruba Saeed, PhD, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

July 12, 2024

Study Completion (Estimated)

July 20, 2024

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 18, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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