Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

NCT06148350 | Completed

• 1 other identifier: AlShifa
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Ischemic

Keywords

Stroke; Disability; Exercise; Balance; Quality of Life.

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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.

Other: Stroke Rehabilitation

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.

Other: Stroke Rehabilitation

Interventions

Stroke Rehabilitation OTHER

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

Group A: Frenkel's Exercise; Group B: Conventional Balance Exercises

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Al- Shifa Physiotherapy Institute /Clinic: lead

Study Sites (1)

Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Motor Activity

Interventions

Stroke Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr. Muhammad Faisal

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: November 28, 2023
• Study Start: March 5, 2021
• Primary Completion: August 30, 2021
• Study Completion: October 5, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)