Stroke, IschemicNCT06663657
Effects of Cognitive Versus Task Oriented Training on Balance, Gait and Daily Activity in Chronic Stroke Patients
A study testing Cognitive Sensorimotor Exercises and Task Oriented Training group in people with Stroke, Ischemic and Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke, Ischemic, Cognitive Impairment, Balance; Distorted
- What is being tested?
- Cognitive Sensorimotor Exercises and Task Oriented Training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2024to 15 Jan 2025
- 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with chronic stroke (6 months to 2 years)
- Patients with the ability to walk independently using aids or orthotics with or without supervision.
- Ability to communicate and follow instructions.
- No problem walking due to ankle contracture.
- No sensory deficiencies of the lower extremities.
- Patients cognition level on MMSE ≥ 24
Who cannot join
- Recent injuries- Patients having musculoskeletal or surgical problems of lower extremity.
- Co-morbid conditions- Cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea.
- Neurological conditions- like brain tumour, demyelinating disease, Parkinson's disease, multiple sclerosis).
- Subjects with auditory and vestibular disorders.
- Cerebellar related problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cognitive Sensorimotor Exercises Versus Task Oriented Training on Balance ,Gait and Activities of Daily Living in Chronic Stroke Patients.
To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.
Read the detailed description
This study will be randomized clinical trial with total of 40 participants with chronic stroke. Patients will be recruited from Riphah rehabilitation centre and National Hospital Lahore. The sampling technique will be non probability convenience sampling technique. The patients will be randomized by lottery method and allocated into two intervention groups.
Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. The assessment tools used will be berg balance test for balance, Dynamic gait index for gait and Modified Barthel index to assess activities of daily livings. Data will be analysed by using SPSS 25 version.
- Conditions
- Stroke, Ischemic, Cognitive Impairment, Balance; Distorted, ADL
- Being tested
- Cognitive Sensorimotor Exercises, Task Oriented Training group
- Keywords
- Stroke, Ischemic, Cognitive Impairment, Balance; Distorted, ADL
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Sensorimotor ExercisesOther
Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks.
Task Oriented Training groupOther
Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| cognitive sensorimotor exercise group | Experimental | Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Receives: Other: Cognitive Sensorimotor Exercises |
| Task based training group | Active comparator | Patients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Receives: Other: Task Oriented Training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The BBS (Berg Balance Scale)
The BBS (Berg Balance Scale) comprises 14 items aimed at evaluating balance function in older adults residing in the community. Each item is scored on a 5-point scale, ranging from 0 to 4, with a total score range of 0 to 56. Higher scores indicate better balance function. The scale exhibits robust psychometric properties, including good internal consistency (Cronbach's α = 0.92-0.98), strong interrater reliability (interclass correlation coefficient = 0.97), and favorable concurrent validity (high correlations [r = 0.91-0.95] with the PASS and the Static Balance Test).
Measured: 10 months
The DGI (Dynamic Gait Index)
The DGI (Dynamic Gait Index) is an eight-item assessment tool designed to evaluate balance, functional mobility, and gait. Notably, the evaluation setting lacked stairs, prompting subjective patient reporting for the stair climbing item to facilitate completion of the measure. Importantly, research supports that omitting the stair component does not compromise the validity or integrity of the DGI. Each of the eight DGI items is scored on a 4-point scale, where a score of 3 indicates no gait dysfunction, 2 reflects minimal dysfunction, 1 represents moderate dysfunction, and 0 denotes severe dysfunction. The total maximum score achievable is 24. The test can be administered in approximately 10 minutes,
Measured: 10 months
The Modified Barthel Index
The Modified Barthel Index is a 100-point scale used to assess a patient's proficiency in performing 10 types of Activities of Daily Living (ADL). Each ADL is assigned a numeric value based on the level of assistance the patient requires. Lower scores on the MBI suggest decreased independence, while higher scores indicate greater self-sufficiency. A perfect score of 100 signifies complete independence in basic ADL, whereas the minimum score of 0 indicates total dependence on assistance for these activities. The MBI provides a quantitative measure of an individual's functional status in daily tasks, aiding in the evaluation of their overall independence.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Apr 2024
- Primary completion1 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Model description
- the patients will be randomized by lottery method and allocated into two intervention groups. Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it include taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest Z hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663657
- Sponsor's protocol ID
- REC/RCR & AHS/24/0201
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2024
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.
PubMed 34563008Sutcu G, Ozcakar L, Yalcin AI, Kilinc M. BOBATH vs. TASK-ORIENTED TRAINING AFTER STROKE: An assessor-blind randomized controlled trial. Brain Inj. 2023 Jun 7;37(7):581-587. doi: 10.1080/02699052.2023.2203519. Epub 2023 Apr 19.
PubMed 37074234Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.
PubMed 38158722
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Sensorimotor Exercises Versus Task Oriented Training on Balance ,Gait and Activities of Daily Living in Chronic Stroke Patients.
- ClinicalTrials.gov ID
- NCT06663657
- Acronym / sponsor ID
- REC/RCR & AHS/24/0201
- Conditions
- Stroke, Ischemic, Cognitive Impairment, Balance; Distorted, ADL
- Keywords
- Stroke, Ischemic, Cognitive Impairment, Balance; Distorted, ADL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 29 Oct 2024 (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.
To determine effects of cognitive sensorimotor exercises versus task oriented training on balance, gait and activities of daily living in chronic stroke patients.
Detailed description
This study will be randomized clinical trial with total of 40 participants with chronic stroke. Patients will be recruited from Riphah rehabilitation centre and National Hospital Lahore. The sampling technique will be non probability convenience sampling technique. The patients will be randomized by lottery method and allocated into two intervention groups.
Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it includes taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks. The assessment tools used will be berg balance test for balance, Dynamic gait index for gait and Modified Barthel index to assess activities of daily livings. Data will be analysed by using SPSS 25 version.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the patients will be randomized by lottery method and allocated into two intervention groups. Patients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. Patients in group B will receive task-oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. Intervention will be applied for 8 weeks it include taking reading 1st at baseline, 2nd reading at 4th week and 3rd reading at 8th week and follow up after 12 weeks
| Arm | Type | Receives |
|---|---|---|
| cognitive sensorimotor exercise group | Experimental | Other: Cognitive Sensorimotor ExercisesPatients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. |
| Task based training group | Active comparator | Other: Task Oriented Training groupPatients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with chronic stroke (6 months to 2 years)
- Patients with the ability to walk independently using aids or orthotics with or without supervision.
- Ability to communicate and follow instructions.
- No problem walking due to ankle contracture.
- No sensory deficiencies of the lower extremities.
Key exclusion criteria (5 listed)
- Recent injuries- Patients having musculoskeletal or surgical problems of lower extremity.
- Co-morbid conditions- Cardiovascular (uncontrolled high blood pressure, diabetes), respiratory problems like dyspnoea.
- Neurological conditions- like brain tumour, demyelinating disease, Parkinson's disease, multiple sclerosis).
- Subjects with auditory and vestibular disorders.
- Cerebellar related problems.
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 |
|---|---|---|
| Cognitive Sensorimotor ExercisesPatients in group A will receive cognitive sensorimotor exercises for 30 minutes, sessions for 5 days per week for 8 weeks. | Other | cognitive sensorimotor exercise group |
| Task Oriented Training groupPatients in group B will receive task oriented training for 30 minutes, sessions for 5 days per week for 8 weeks. | Other | Task based training group |
Primary outcome
The BBS (Berg Balance Scale)
Time frame: 10 months
The BBS (Berg Balance Scale) comprises 14 items aimed at evaluating balance function in older adults residing in the community. Each item is scored on a 5-point scale, ranging from 0 to 4, with a total score range of 0 to 56. Higher scores indicate better balance function. The scale exhibits robust psychometric properties, including good internal consistency (Cronbach's α = 0.92-0.98), strong interrater reliability (interclass correlation coefficient = 0.97), and favorable concurrent validity (high correlations [r = 0.91-0.95] with the PASS and the Static Balance Test).
The DGI (Dynamic Gait Index)
Time frame: 10 months
The DGI (Dynamic Gait Index) is an eight-item assessment tool designed to evaluate balance, functional mobility, and gait. Notably, the evaluation setting lacked stairs, prompting subjective patient reporting for the stair climbing item to facilitate completion of the measure. Importantly, research supports that omitting the stair component does not compromise the validity or integrity of the DGI. Each of the eight DGI items is scored on a 4-point scale, where a score of 3 indicates no gait dysfunction, 2 reflects minimal dysfunction, 1 represents moderate dysfunction, and 0 denotes severe dysfunction. The total maximum score achievable is 24. The test can be administered in approximately 10 minutes,
The Modified Barthel Index
Time frame: 10 months
The Modified Barthel Index is a 100-point scale used to assess a patient's proficiency in performing 10 types of Activities of Daily Living (ADL). Each ADL is assigned a numeric value based on the level of assistance the patient requires. Lower scores on the MBI suggest decreased independence, while higher scores indicate greater self-sufficiency. A perfect score of 100 signifies complete independence in basic ADL, whereas the minimum score of 0 indicates total dependence on assistance for these activities. The MBI provides a quantitative measure of an individual's functional status in daily tasks, aiding in the evaluation of their overall independence.
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 21 Feb 2025.
- Background: PubMed 34563008Kim KH, Jang SH. Effects of Cognitive Sensory Motor Training on Lower Extremity Muscle Strength and Balance in Post Stroke Patients: A Randomized Controlled Study. Clin Pract. 2021 Sep 14;11(3):640-649. doi: 10.3390/clinpract11030079.
- Background: PubMed 37074234Sutcu G, Ozcakar L, Yalcin AI, Kilinc M. BOBATH vs. TASK-ORIENTED TRAINING AFTER STROKE: An assessor-blind randomized controlled trial. Brain Inj. 2023 Jun 7;37(7):581-587. doi: 10.1080/02699052.2023.2203519. Epub 2023 Apr 19.
- Background: PubMed 38158722Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.
- 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.
zeest Z hashmi, MSNMPT 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 Cognitive Sensorimotor Exercises and Task Oriented Training group in people with Stroke, Ischemic and Cognitive Impairment, 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 6 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 21 Feb 2025. 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?
The BBS (Berg Balance Scale) (time frame: 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06663657, which also lists 3 linked publications.
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 21 Feb 2025.