NCT06509646

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

July 19, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 15, 2024

Last Update Submit

July 18, 2024

Conditions

Keywords

Tai Chi ExerciseFrenkel's ExerciseStrokeADLFall RiskBalance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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)

    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

    12th week

Study Arms (2)

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.

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

Other: Frenkel's Exercise

Interventions

• 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

Goup A (Tia Chi 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

Group B (Frenkel's Exercise )

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alveena fatima

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, phd

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

February 1, 2024

Primary Completion

July 12, 2024

Study Completion

July 20, 2024

Last Updated

July 19, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations