Subacute StrokeNCT06749002
Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients
A study testing Turning based specific training along with functional Muscle training and turning based specific training. in people with Subacute Stroke and Chronic Stroke, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Stroke is the leading cause of disability leading to Gait and balance dysfunction leading to decreased Quality of Life. Difficulty in turning is a major target in Gait Rehabilitation. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Subacute Stroke, Chronic Stroke, Balance
- What is being tested?
- Turning based specific training along with functional Muscle training and turning based specific training.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group: 45-60 years onwards
- Both males and females
- Subacute and chronic stroke (MCA >6months)
- MMSE score 25 or higher.
- FAC -3
Who cannot join
- Hemorrhagic stroke.
- Patients with Epilepsy.
- Patients with other neurological conditions like Alzheimer, Parkinson and other Dementias.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, Punjab Province, 44000
Sana Khalid, MS-NMPT, +92 3444218174, sana.khalid@fui.edu.pk
About this study
Stroke is the leading cause of disability leading to Gait and balance dysfunction leading to decreased Quality of Life. Difficulty in turning is a major target in Gait Rehabilitation. Task specific exercises has proven to be effective in all stages of stroke rehabilitation, therefore Turning based specific training is to be used in order to improve turning and balance in post stroke patients moreover functional strength training of lower extremities prove to be more effective than traditional training.
Read the detailed description
The objectives of this study are:
- To determine the additional effects of functional muscle training with turning based specific training on turning in Gait among post stroke patients.
- To the determine the additional effects of functional muscle training with turning based specific training on balance in post stroke patients.
- To determine the additional effects of functional muscle training with turning based specific training on Quality of LIfe aming post stroke patients.
HYPOTHESIS:
Alternate hypothesis 1.1HA-There will be a statistically significant difference of muscle training in addition with turning based specific training in turning among post stroke patients (p<0.05).
- 2HA- There will be statistically significant difference between muscle training in addition with turning based specific training on balance in post stroke patients (p<0.05).
Null hypothesis:
1.1H0 -There will be statistically no significant difference of muscle training with turning based specific training on turning in Gait among post-stroke patients (p>0.05) 2 .2HO-There will be statistically no significant difference of muscle training with turning specific training on balance in post stroke patients (p>0.05)Research Design: Experimental study. Randomized Control Trial
Clinical setting: Rehabilitation department, Fauji Foundation Hospital.
Selection Criteria:
Inclusion Criteria
- Age group: 45-60 years onwards
- Both males and females
- Patients with subacute and chronic stroke (MCA >6months)
- MMSE- 25 or higher, Functional ambulatory capacity-3
Exclusion Criteria
- Hemorrhagic stroke.
- Patients with epilepsy
- Patients with other neurological conditions loke Alzheimer, parkinsons and dementias.
Sampling technique: non-probability purposive sampling.
Outcome Measures:
TURNING: 1) Standing Turn Test, 2) Figure of 8 Test. BALANCE: 1) Berg Balance Scale, 2) Timed up and Go Test, 3) Modified 4 square step Test.
Outcome measures will be evaluated at baseline and then after 6 weeks of intervention.
Experimental Group (A) = This group will recieve Turning based specific training along with Functional muscle training for 6 weeks.
Control group (B) = This group will recieive Turning Based Specific Training only for 6 weeks
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.
Significance of the study:
Turning is a major component of ambulation. Difficulty in turning results in increased risk of fall. Stroke results in step asymmetry which increases difficulty in changing direction.
There is sufficient evidence available for normal gait training but limited protocols for targetting turning in Gait.
The current study aims to fill this gap by providing research data and developing a treatment protocol.
- Conditions
- Subacute Stroke, Chronic Stroke, Balance
- Being tested
- Turning based specific training along with functional Muscle training, turning based specific training.
- Keywords
- Stroke, chronic stroke, functional muscle training, Turning based specific training, Turning in Gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turning based specific training along with functional Muscle trainingProcedure or surgery
Experimental group will receive Turning based specific training protocol for 6 weeks along with functional muscle training, training will be done on alternate days.
Functional muscle training:
Details: Week 1-6: 3 days a week on alternate days.
Hip Abductors:
Side lying leg raises Single leg squatting Standing leg wall press Progressing to Adding resistance bands
Hip adductors:
Side lying adduction Standing Adduction Progress to adding resistance bands
Hip Flexors:
Standing leg lift Straight leg raises Progress to adding resistance bands
Hip Extensors:
Prone lying raises Standing single leg extension Progress to adding resistance bands
Plantarflexors/ DorsiFlexors:
Plantarflexors:
Plantarflexion against resistance Toe raises
Dorsiflexors:
Dorsiflexion against resistance Heel raises
Hip external rotators:
Sitting-externally rotate hip 0-30° Add resistance bands
Hip Internal rotators:
Sitting-internally rotate the hip 0-30° Add resistance bands.
turning based specific training.Procedure or surgery
Week 1:
90 Degrees turns on the spot
Visual cues to follow
Week 2-3:
90 degrees turns on the spot
Figure of 8 walking
Visual cues to follow
Week 4-5:
90 Degrees turns on the spot
Figure of 8 walking
Step across body
Braiding
Week 6:
90 degree turns on the spot
Figure of 8 walking
Step across body
Braiding
Visual cues to follow
Obstacle avoidance
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | It includes participants receiving Functional muscle training along with Turning based specific training over a period of 6 weeks. Receives: Procedure: Turning based specific training along with functional Muscle training |
| Control Group | Active comparator | It includes participants recieving Turning based specific training only for 6 weeks. Receives: Procedure: turning based specific training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turning performance.
Standing turn test will be used for turning performance
Measured: 6 weeks
turning ability
Figure of 8 test will be used for turning ability
Measured: 6 weeks
Balance
Berg Balance Scale will be used to assess balance
Measured: 6 weeks
Balance
Four square stand test will be used for this
Measured: 6 weeks
Secondary outcomes (1)
Balance
Timed up and go test will be used for this
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start20 Jun 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies 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
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749002
- Sponsor's protocol ID
- FUI/CTR/2024/61
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Functional Muscle Training With Turning Based Specific Training During Turning in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT06749002
- Acronym / sponsor ID
- FUI/CTR/2024/61
- Conditions
- Subacute Stroke, Chronic Stroke, Balance
- Keywords
- Stroke, chronic stroke, functional muscle training, Turning based specific training, Turning in Gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 27 Dec 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.
Stroke is the leading cause of disability leading to Gait and balance dysfunction leading to decreased Quality of Life. Difficulty in turning is a major target in Gait Rehabilitation. Task specific exercises has proven to be effective in all stages of stroke rehabilitation, therefore Turning based specific training is to be used in order to improve turning and balance in post stroke patients moreover functional strength training of lower extremities prove to be more effective than traditional training.
Detailed description
The objectives of this study are:
- To determine the additional effects of functional muscle training with turning based specific training on turning in Gait among post stroke patients.
- To the determine the additional effects of functional muscle training with turning based specific training on balance in post stroke patients.
- To determine the additional effects of functional muscle training with turning based specific training on Quality of LIfe aming post stroke patients.
HYPOTHESIS:
Alternate hypothesis 1.1HA-There will be a statistically significant difference of muscle training in addition with turning based specific training in turning among post stroke patients (p<0.05).
- 2HA- There will be statistically significant difference between muscle training in addition with turning based specific training on balance in post stroke patients (p<0.05).
Null hypothesis:
1.1H0 -There will be statistically no significant difference of muscle training with turning based specific training on turning in Gait among post-stroke patients (p>0.05) 2 .2HO-There will be statistically no significant difference of muscle training with turning specific training on balance in post stroke patients (p>0.05)Research Design: Experimental study. Randomized Control Trial
Clinical setting: Rehabilitation department, Fauji Foundation Hospital.
Selection Criteria:
Inclusion Criteria
- Age group: 45-60 years onwards
- Both males and females
- Patients with subacute and chronic stroke (MCA >6months)
- MMSE- 25 or higher, Functional ambulatory capacity-3
Exclusion Criteria
- Hemorrhagic stroke.
- Patients with epilepsy
- Patients with other neurological conditions loke Alzheimer, parkinsons and dementias.
Sampling technique: non-probability purposive sampling.
Outcome Measures:
TURNING: 1) Standing Turn Test, 2) Figure of 8 Test. BALANCE: 1) Berg Balance Scale, 2) Timed up and Go Test, 3) Modified 4 square step Test.
Outcome measures will be evaluated at baseline and then after 6 weeks of intervention.
Experimental Group (A) = This group will recieve Turning based specific training along with Functional muscle training for 6 weeks.
Control group (B) = This group will recieive Turning Based Specific Training only for 6 weeks
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.
Significance of the study:
Turning is a major component of ambulation. Difficulty in turning results in increased risk of fall. Stroke results in step asymmetry which increases difficulty in changing direction.
There is sufficient evidence available for normal gait training but limited protocols for targetting turning in Gait.
The current study aims to fill this gap by providing research data and developing a treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Turning based specific training along with functional Muscle trainingIt includes participants receiving Functional muscle training along with Turning based specific training over a period of 6 weeks. |
| Control Group | Active comparator | Procedure: turning based specific training.It includes participants recieving Turning based specific training only for 6 weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age group: 45-60 years onwards
- Both males and females
- Subacute and chronic stroke (MCA >6months)
- MMSE score 25 or higher.
- FAC -3
Key exclusion criteria (3 listed)
- Hemorrhagic stroke.
- Patients with Epilepsy.
- Patients with other neurological conditions like Alzheimer, Parkinson and other Dementias.
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 |
|---|---|---|
| Turning based specific training along with functional Muscle trainingExperimental group will receive Turning based specific training protocol for 6 weeks along with functional muscle training, training will be done on alternate days. Functional muscle training: Details: Week 1-6: 3 days a week on alternate days. Hip Abductors: Side lying leg raises Single leg squatting Standing leg wall press Progressing to Adding resistance bands Hip adductors: Side lying adduction Standing Adduction Progress to adding resistance bands Hip Flexors: Standing leg lift Straight leg raises Progress to adding resistance bands Hip Extensors: Prone lying raises Standing single leg extension Progress to adding resistance bands Plantarflexors/ DorsiFlexors: Plantarflexors: Plantarflexion against resistance Toe raises Dorsiflexors: Dorsiflexion against resistance Heel raises Hip external rotators: Sitting-externally rotate hip 0-30° Add resistance bands Hip Internal rotators: Sitting-internally rotate the hip 0-30° Add resistance bands. | Procedure or surgery | Experimental group |
| turning based specific training.Week 1: 90 Degrees turns on the spot Visual cues to follow Week 2-3: 90 degrees turns on the spot Figure of 8 walking Visual cues to follow Week 4-5: 90 Degrees turns on the spot Figure of 8 walking Step across body Braiding Week 6: 90 degree turns on the spot Figure of 8 walking Step across body Braiding Visual cues to follow Obstacle avoidance | Procedure or surgery | Control Group |
Primary outcome
Turning performance.
Time frame: 6 weeks
Standing turn test will be used for turning performance
turning ability
Time frame: 6 weeks
Figure of 8 test will be used for turning ability
Balance
Time frame: 6 weeks
Berg Balance Scale will be used to assess balance
Balance
Time frame: 6 weeks
Four square stand test will be used for this
1 secondary outcome
Balance
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Related trials for Subacute Stroke
Recruiting
Effects of Contralateral Gravity Eliminated Gluteus Medius and Ipsilateral Quadratus Lumborum Strengthening on Pelvic Alignment, Balance and Functional Mobility on Subacute Stroke Patients
Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Analysis of Electroencephalogram (EEG) Changes in Subacute Stroke Patients
Stroke, Electroencephalogram (EEG)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turning based specific training along with functional Muscle training and turning based specific training. in people with Subacute Stroke and Chronic Stroke, run by Foundation University Islamabad 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 3 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahnoor Khan, DPT (+92 3331979569, imahnoorphysio28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turning performance. (time frame: 6 weeks). 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 27 Dec 2024.