- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05059704
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
January 13, 2023 updated by: Riphah International University
Effects of Circuit Class Training vs. Individual, Task Specific Training on Upper Extremity Function in Chronic Stroke Patient
Due to minimal volitional activation of the impaired arm, these individuals are less able to engage in activities of daily living (ADL's).
Moreover, simultaneous use of the hand and arm are needed throughout ADL's.
The effects of these two approaches (circuit class training and individual task-specific training) on upper extremity function and activities of daily living (ADL's) have not yet been clearly identified, and studies on its effects on chronic stroke patients are limited.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
several research found that circuit training improved various functional parameters after stroke.
And most of the circuit based tasks from the published studies were focused on the leg strength, walking speed, distance and balance etc.
Previous literature found that circuit class training is effective in improving upper extremity function in chronic stroke patients disregarding the type of stroke and the results of that study are not generalized for chronic stroke patients with upper extremity deficit.
Secondly, circuit class training and task-specific training are effective for improving upper limb function following a stroke but in the acute stage.
In fact, there is no evidence in which comparison of these two approaches has been done in chronic stroke patients and thirdly, between these two approaches which approach is more effective towards improving upper limb function in chronic stage.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Punjab
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Gujrāt, Punjab, Pakistan
- Al Mustafa Trust Medical and Physiotherapy Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Mini-Mental State Examination score more than 24
- Chronic stage (i.e. post-stroke duration of 6 months)
- Single episode of stroke
- MAS of 1 to 3 at upper extremity.
- MRS of ≤ 3 at lower extremity.
- MCA stroke
- Scores 32 to 47 on Fugl-Meyer Upper Extremity Scale (FMA-UE)
Exclusion Criteria:
- Orthopedic conditions that affect the UE function.
- Other neurological conditions, like PD, MS etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Circuit Class Training
Patients will participate in a total of 1.5hour/day for 8 weeks with a 1:3 (therapist to patient).
The circuit will be divided into 5 specific stations, 5 to 10 minutes for warm-up tasks and 15 to 20 minutes on each station as tailored to the patient's activity level
|
Station 1 will include tasks for warm-up specific for upper extremity, station 2 will include shoulder exercises, station 3 will include elbow exercises, station 4 will include wrist exercises and station 5 will include hand activities and functional training.
Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.
|
|
Active Comparator: Individual Task specific training
Patients will participate in a total of 1.5hour/day for 8 weeks with 1:1 (therapist to patient) ratio.
During each session, all patients will perform 5 to 10 minutes warm-up tasks, then practiced the selected tasks for the rest of the time.
|
Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment Scale
Time Frame: 8 weeks
|
The Fugl-Meyer Assessment is the gold standard to assess motor function of post-stroke hemiparesis.
The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment.
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale
Time Frame: 8 weeks
|
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform
|
8 weeks
|
|
Stroke Specific-Quality of Life Urdu Version (SS-QOL)
Time Frame: 8 weeks
|
The SS-QOL scale is a health-related outcome measure that comprises 49 items in 12 areas of vision, mobility, thinking, social roles, self-care, language, personality, family roles, work/productivity, upper limb function, mood and energy.
It covers a more extensive inclusion of capacities ordinarily influenced by stroke.
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2021
Primary Completion (Actual)
July 31, 2022
Study Completion (Actual)
August 31, 2022
Study Registration Dates
First Submitted
September 17, 2021
First Submitted That Met QC Criteria
September 17, 2021
First Posted (Actual)
September 28, 2021
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 13, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01036 Farwa Azmat
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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