Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

Sponsor

Al- Shifa Physiotherapy Institute /Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT06148350

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Ischemic	Other: Stroke Rehabilitation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 5, 2021

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Oct 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A: Frenkel's Exercise 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.	Other: Stroke Rehabilitation Both the groups received interventions three days/week for 30-60 minutes for four weeks
Active Comparator: Group B: Conventional Balance Exercises 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.	Other: Stroke Rehabilitation Both the groups received interventions three days/week for 30-60 minutes for four weeks

Arm

Intervention/Treatment

Experimental: Group A: Frenkel's Exercise

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.

Other: Stroke Rehabilitation

Both the groups received interventions three days/week for 30-60 minutes for four weeks

Active Comparator: Group B: Conventional Balance Exercises

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.

Other: Stroke Rehabilitation

Both the groups received interventions three days/week for 30-60 minutes for four weeks

Outcome Measures

Primary Outcome Measures

Berg Balance Scale [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.
Berg Balance Scale [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.
Stroke-Specific Quality of Life Scale [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.
Stroke-Specific Quality of Life Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.