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Completed

NCT Number: NCT06148350

Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

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.

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Key information

Conditions

Stroke, Ischemic Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Motor Activity Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stroke Rehabilitation

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Al- Shifa Physiotherapy Institute /Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2023
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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