StrokeNCT05059704
Circuit Class Training vs. Individual, Task Specific Training in Chronic Stroke Patient
A study testing Circuit Class Training and Individual Task specific training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Circuit Class Training and Individual Task specific training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jun 2021to 31 Aug 2022
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Orthopedic conditions that affect the UE function.
- Other neurological conditions, like PD, MS etc.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Al Mustafa Trust Medical and Physiotherapy Centre
Dhok Gujra, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Circuit Class Training, Individual Task specific training
- Keywords
- Spasticity, Motor function
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit Class TrainingOther
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.
Individual Task specific trainingOther
Variables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability.
| Study group | Role | What they receive |
|---|---|---|
| Circuit Class Training | Experimental | 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 Receives: Other: Circuit Class Training |
| Individual Task specific training | Active comparator | 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. Receives: Other: Individual Task specific training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment Scale
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.
Measured: 8 weeks
Secondary outcomes (2)
Modified Ashworth Scale
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
Measured: 8 weeks
Stroke Specific-Quality of Life Urdu Version (SS-QOL)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start26 Jun 2021
- Primary completion31 Jul 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mirza Obaid Baig, MSPT(NMR), Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059704
- Sponsor's protocol ID
- REC/01036 Farwa Azmat
- Status last verified
- Jan 2023
- First submitted
- 17 Sep 2021
- Last updated
- 17 Jan 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Circuit Class Training vs. Individual, Task Specific Training on Upper Extremity Function in Chronic Stroke Patient
- ClinicalTrials.gov ID
- NCT05059704
- Acronym / sponsor ID
- REC/01036 Farwa Azmat
- Conditions
- Stroke
- Keywords
- Spasticity, Motor function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 26 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Sep 2021 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circuit Class Training | Experimental | Other: Circuit Class TrainingPatients 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 |
| Individual Task specific training | Active comparator | Other: Individual Task specific trainingPatients 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Orthopedic conditions that affect the UE function.
- Other neurological conditions, like PD, MS etc.
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 |
|---|---|---|
| Circuit Class TrainingStation 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. | Other | Circuit Class Training |
| Individual Task specific trainingVariables such as speed, or/and resistance will progressively increase in difficulty according to each patient's ability. | Other | Individual Task specific training |
Primary outcome
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.
2 secondary outcomes
Modified Ashworth Scale
Time frame: 8 weeks
Stroke Specific-Quality of Life Urdu Version (SS-QOL)
Time frame: 8 weeks
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 17 Jan 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.
Mirza Obaid Baig, MSPT(NMR) principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit Class Training and Individual Task specific training in people with Stroke, run by Riphah International University 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 7 inclusion and 2 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 17 Jan 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?
Fugl-Meyer Assessment Scale (time frame: 8 weeks). 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 17 Jan 2023; AzTrials last refreshed its copy on 3 Nov 2026.