Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients

Stroke, Ischemic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06148350
• Other study ID #: AlShifa
• Status: Completed
• Phase: N/A
• Start date: March 5, 2021
• Est. completion date: October 5, 2021

Study information

• Verified date: November 2023
• Source: Al- Shifa Physiotherapy Institute /Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 5, 2021
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Other:
• Stroke Rehabilitation
Both the groups received interventions three days/week for 30-60 minutes for four weeks

Locations

Country	Name	City	State
Pakistan	Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Al- Shifa Physiotherapy Institute /Clinic

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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