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Clinical Trials/NCT06148350
NCT06148350CompletedNot Applicable

Regaining Balance and Quality of Life: The Impact of Frenkel's Exercises in Patients With Sub-Acute Ischemic Stroke-A Randomized Controlled Trial

Al- Shifa Physiotherapy Institute /Clinic1 site in 1 country50 target enrollmentStarted: March 5, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
Stroke-Specific Quality of Life Scale

Study Overview

Brief Summary

This single-blinded, randomized controlled was aimed to compare the efficacy of Frenkel's and Conventional Balance Exercises in improving balance and quality of life in patients with subacute ischemic stroke. The participants of Group A received 'Frenkel's Exercises'. In contrast, Group B participants received 'Conventional Balance Exercise' interventions three days/week for 30-60 minutes for four weeks. The data was collected pre and post-treatment on the Berg Balance Scale and Stroke Specific-Quality of Life.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
35 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged between 35 to 75 years.
  • •First-ever ischemic stroke and hemiparesis within 7 to 30 days of onset.
  • •Reduced proprioception of the lower limb with a score of ≤12 on the NSA (kinesthetic and tactile sensation test),
  • •Able to comprehend tasks and follow directions with a score of ≥21 points on the Mini-Mental State Examination (MMSE).
  • •Able to independently perform standing motions for ≥1 minute.

Exclusion Criteria

  • •Patients with lower limb fractures within 6 months.
  • •Severe pain.
  • •Limited range of motion.
  • •Cerebellar ataxia.
  • •Medically unstable.

Arms & Interventions

Group A: Frenkel's Exercise

Experimental

Frenkel's exercises spanned four weeks with distinct positions:

Week 1: Recumbent position, focusing on heel sliding, knee, and hip movements. Week 2: Seated exercises, emphasizing leg elevation and standing from a chair. Week 3: Erect posture activities, including forward, sideways, and backward walking with diverse steps and turns.

Week 4: Comprehensive exercises across all positions, emphasizing varied movements.

Each exercise set included 8-10 repetitions with 1-2 minutes of rest.

Intervention: Stroke Rehabilitation (Other)

Group B: Conventional Balance Exercises

Active Comparator

Structured program with 8-10 reps and 1-2 min rest:

I. Strengthening: Targets hips, knees, and ankles-squats, lunges, leg presses. II. Weight-Shifting: Enhances balance with side-to-side, forward-backward steps.

III. Trunk Stabilization: Improves core control-planks, crunches, twists. IV. Proprioception: Balance board exercises challenge spatial awareness, performed under physiotherapist supervision.

Intervention: Stroke Rehabilitation (Other)

Outcomes

Primary Outcomes

Stroke-Specific Quality of Life Scale

Time Frame: After 4-weeks

The scale measures the quality of life of participants. There are 49 items on the 5-point scale, with the lowest score being 49 and the highest being 245. The higher the quality of life, the lower the score. A Cronbach's alpha of 0.80 was reported as the test's reliability.

Berg Balance Scale

Time Frame: After 4-weeks

It has 14 items on a 5-point scale (0-4) and a total score of 56. It has a very high reliability rating, with an ICC of 0.98. Participants who receive scores of 0 to 20 use wheelchairs, those who receive scores of 21 to 40 need aid or assistance, and those who receive scores of 41 or higher have independent gait.

Berg Balance Scale

Time Frame: Baseline

The scale assesses dynamic balance skills with 14 items on a 5-point scale (0-4) and a total score of 56. It has a very high-reliability rating, with an ICC of 0.98. Participants who receive scores of 0 to 20 use wheelchairs, those who receive scores of 21 to 40 need aid or assistance, and those who receive scores of 41 or higher have independent gait.

Stroke-Specific Quality of Life Scale

Time Frame: Baseline

The scale measures the quality of life of participants. There are 49 items on the 5-point scale, with the lowest score being 49 and the highest being 245. The higher the quality of life, the lower the score. A Cronbach's alpha of 0.80 was reported as the test's reliability.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Al- Shifa Physiotherapy Institute /Clinic
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Muhammad Faisal

Mr. Muhammad Faisal

Al- Shifa Physiotherapy Institute /Clinic

Study Sites (1)

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