- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07646418
Combined Effects of LIRT-BFR Therapy in Post- Stroke Patients
Combined Effects of Low Intensity Resistance Training With Blood Flow Restriction Therapy on Upper Limb Strength, Forward Reach and Sensorimotor Function in Post-Stroke Patients
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, PhD
- Phone Number: 03324390125
- Email: Imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Sialkot, Punjab Province, Pakistan, 39000
- Recruiting
- Amin Welfare & Teaching Hospital
-
Contact:
- Dr. Aqsa Gulzar Ahmed, Mbbs
- Phone Number: 03484071699
- Email: aqsachodhary504@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• 50 to 70 year of age (5)
- Both males and females (5)
- Generalized stroke population (both ischemic and hemorrhagic stroke) (9).
- Post stroke patient after 1 month (5)
- Barthel index scores ≥ 20 (10)
- Spasticity level according to Modified Ashworth scale should be 1/+1 grade in the affected upper limb(7)
- Muscle strength at grade 3 according to MMT of affected upper limb (7)
Exclusion Criteria:
• People with a history of mental/cognitive illness (9)
- History of transient ischemic attack (TIA) or recurrent stroke (8)
- Diabetes with peripheral neuropathy (5)
- Having resting blood pressure above 160/100 mmHg even after taking medications
- Cardiovascular comorbidity (heart failure, unstable angina, aortic stenosis)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low intensity resistance training with Blood flow restriction therapy
Low intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands. Cuff pressure should be 150-160 mmHg |
Low intensity resistance training with BFR in U.L Using B.P cuff at proximal site of U.L 40% of 1RM Resistance training of U.L will be performed using small weights (1-2kg) and resistance bands. Cuff pressure should be 150-160 mmHg |
|
Active Comparator: Conventional Physical Therapy Protocol
Upper extremity Motor skills: Reaching, Grasping Strengthening Exercises, CIMT Sensory skills: By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs. Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability |
Upper extremity Motor skills: Reaching, Grasping Strengthening Exercises, CIMT Sensory skills: By manually exploring different objects, temperature and pressure Dull stroke through cotton, Sharp stroke through common pin, needle to retrain sensory inputs. Upper extremity Strengthening exercises Strengthening Exercises through Thera bands, 1 or 2 kg dumbels Forward Reaching exercises with stable lower extremity Reaching exercises with stable lower extremity Standing position,core engagement, Arm position controlled movement minimizing trunk and hip movement, perturbations technique to improve stability. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory Motor Function of upper Limb
Time Frame: Baseline and post 6 weeks
|
Fugl-Meyer Assessment test for Upper extremity (FMA-UE)
|
Baseline and post 6 weeks
|
|
Upper Extremity strength
Time Frame: Baseline and post 6 weeks
|
Action Research Arm Test (ARAT)
|
Baseline and post 6 weeks
|
|
Forward reach Distance
Time Frame: Baseline and post 6 weeks
|
Functional Reach Test (FRT)
|
Baseline and post 6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aiza Yousaf, MS-OMPT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/25/0242
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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