Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

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

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 Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Other: Stroke Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with lower limb fractures within 6 months.
2. Severe pain.
3. Limited range of motion.
4. Cerebellar ataxia.
5. Medically unstable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	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.	Baseline
Berg Balance Scale	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.	After 4-weeks
Stroke-Specific Quality of Life Scale	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.	Baseline
Stroke-Specific Quality of Life Scale	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.	After 4-weeks

Collaborators and Investigators

• Sponsor: Al- Shifa Physiotherapy Institute /Clinic

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): August 30, 2021
• Study Completion (Actual): October 5, 2021

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Exercise; Balance; Stroke; Disability; Quality of Life.
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Ischemia
• Other Study ID Numbers: AlShifa

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