Stroke, IschemicNCT06148350
Frenkel's Exercises for Sub-Acute Ischemic Stroke Patients
A study testing Stroke Rehabilitation in people with Stroke, Ischemic, run by Al- Shifa Physiotherapy Institute /Clinic at 1 site in Pakistan.
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'. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Stroke Rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2021to 5 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with lower limb fractures within 6 months.
- Severe pain.
- Limited range of motion.
- Cerebellar ataxia.
- Medically unstable.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al-Shifa Physiotherapy Clinic Qasimabad Hyderabad
Karachi, Sindh
About this study
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
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
- Being tested
- Stroke Rehabilitation
- Keywords
- Stroke, Disability, Exercise, Balance, Quality of Life.
- Medical subject headings
- Ischemic Stroke, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke RehabilitationOther
Both the groups received interventions three days/week for 30-60 minutes for four weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Stroke Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start5 Mar 2021
- Primary completion30 Aug 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al- Shifa Physiotherapy Institute /Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Faisal, Al- Shifa Physiotherapy Institute /Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148350
- Sponsor's protocol ID
- AlShifa
- Status last verified
- Nov 2023
- First submitted
- 19 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06148350
- Acronym / sponsor ID
- AlShifa
- Conditions
- Stroke, Ischemic
- Keywords
- Stroke, Disability, Exercise, Balance, Quality of Life.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Al- Shifa Physiotherapy Institute /ClinicUniversity, hospital or other
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Frenkel's Exercise | Experimental | Other: Stroke RehabilitationFrenkel'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. |
| Group B: Conventional Balance Exercises | Active comparator | Other: Stroke RehabilitationStructured 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients with lower limb fractures within 6 months.
- Severe pain.
- Limited range of motion.
- Cerebellar ataxia.
- Medically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke RehabilitationBoth the groups received interventions three days/week for 30-60 minutes for four weeks | Other | Group A: Frenkel's Exercise, Group B: Conventional Balance Exercises |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke Rehabilitation in people with Stroke, Ischemic, run by Al- Shifa Physiotherapy Institute /Clinic at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.