- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07642154
Comparison Between LL Sesorimotor Training and WBB Therapy on PS, DB and FOF in Post Stroke Patients
Comparison Between Lower Limb Sensorimotor Training and Whole-Body Vibration Therapy on Postural Stability, Dynamic Balance and Fear of Fall in Post Stroke Patients.
Stroke is a neurological disorder causing 70-80 percent deaths in the low income and developing countries. Patients commonly present with common impairments associated with balance, proprioception, poor gait, speech impairment and posture which affect the activities of daily living along with increased risk and fear of fall. This negatively impacts patients' mobility, confidence and role in the society. Lower limb sensorimotor training targets the integration of sensory and motor systems enhancing tactile stimulation, balance and proprioception; whereas whole body vibration stimulates muscle spindles and mechanoreceptors via mechanical oscillations that may promote reflexive muscle contractions, improve muscle tone, and enhance postural responses. The aim of this study is to find the comparative effects of lower limb sensorimotor training and whole-body vibration therapy on balance, posture and fear of fall in post stroke patients.
This study will be a randomized clinical trial. Non probability convenience sampling will be used to recruit 42 patients of either gender, aged 50-65 years, and diagnosed with stroke. This study will be carried out in Saira Memorial Hospital, Lahore. The participants will be randomly allocated to Group A and Group B through computerized table generator method. Each group will be given conventional physical therapy treatment as a baseline which includes range of motion exercises, balance and gait training. Group A will receive lower limb sensorimotor training, whereas group B will receive whole body vibration therapy. Each group will perform their respective exercises 45 minutes, three times a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Berg Balance scale for dynamic balance, falls efficacy scale for risk of fall and Nottingham sensory assessment scale for sensory assessment. Data will be analyzed by SPSS version 26.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr. Mohammad Hassan, MS
- Phone Number: +923214375335
- Email: drhassandpt@gmail.com
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 42000
- Recruiting
- Saira Memorial Hospital
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Contact:
- Dr Mohammad Hassan, MS-SPT
- Phone Number: +923214375335
- Email: drhassandpt@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both male and female ranging from 50-65 years.
- Definitive diagnosis of stroke .
- Having sensory issues due to stroke in lower extremities.
- Those who did not have a problem with walking due to other diseases other than stroke.
- Having score less than 45 on berg balance scale.
- Having no wounds, infections, and skin diseases in the feet, not taking medications such as nitroglycerin, dopamine, and dobutamine.
- Having no history of mental illness, no suffering from osteoporosis, and not having neurological diseases. (7)
Exclusion Criteria:
- Vestibular problems.
- Severe cognitive decline and aphasia
- Systemic diseases.
- Cerebellar-related diseases.
- Having acute and critical conditions during the intervention. (14)
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: Lower Limb Sensorimotor Training Exercises Group
Sensorimotor training Participants of this group will be given task-specific training (reaching and walking activities), sensory stimulation training (tactile and proprioceptive activities), balance and postural control training (single leg stance and balance board training), and bilateral training (active recovery such as slow walking and light movements, constraint-induced movement therapy including mirror therapy), as well as practice of functional activities of daily living (bathing, combing, and eating with utensils). (19) |
Component Frequency Intensity Time (minutes) Type Task- specific training 3 times per week Low to moderate 5 minutes Participants will perform reaching and walking activities. Sensory stimulation) 3 times/week Low to moderate 5 minutes Tactile and proprioceptive activities will be performed on participants. Balance/pos ture control 3 times/week Low to moderate 5 minutes Single leg stance and balance board training will be given to the patients. Bilateral training 3 times per week Low to moderate 5 minutes Active recovery (slow walking/light movement) exercises will be guided to the participants. Constraint- Induced Movement Therapy (CIMT) 3 times/week Low to Moderate 5 minutes Participants will involve in Mirror therapy. Functional activities (ADLs) 3 times per week Low to moderate 5 minutes Participants will perform functional activities like combing hair, pouring water, Eating with utensils, folding towels or clothes. |
|
Experimental: Whole Body Vibration Training Group
Participants in this group will be given whole body vibration therapy including standing while vibrating (feet shoulder width apart and knees slightly bent on whole body vibrator), mini squats performed while vibrating, seated or assisted vibration (participants will sit on a chair or cushion placed on the platform and receives vibration therapy), upper body training while vibrating (participants will perform task-oriented upper limb exercises along with vibration therapy).
The frequency of vibration for lower limb will be 11-z.(20)
|
Component Frequency Intensity Time (minutes) Type Static Standing with vibration 3 times per week Low to moderate 5 minutes Participants stand with feet shoulder-width apart and knees slightly bent on whole body vibrator, receiving whole body vibration therapy. Mini Squats Performed while vibrating 3 times per week Low to moderate 5 minutes Participants perform min squats while receiving whole body vibration therapy Seated or Assisted Vibration 3 times per week Low to moderate 5 minutes Participants sit on a chair or cushion placed on the platform and receives vibration therapy. Upper Body Training while vibrating 3 times per week Low to moderate 5 minutes Participants will perform task-oriented upper limb exercises along with vibration therapy Vibration 3 times per Low to 5 minutes Participants will receive therapy along with functional tasks week moderate whole body vibration therapy while performing functional tasks like pegboard training |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Stability
Time Frame: 8 Weeks
|
The Falls Efficacy Scale International is a measure of fear of falling or concerns about falling, developed as part of the Prevention of Falls Network Europe project between 2003 and 2006.
It is a 16-item questionnaire, useful for researchers and clinicians interested in assessing fear of falling.
The total score ranges from 16-64, with levels of concern classified as follows: Low Concern (16-19), indicating minimal concern about falling when engaging in daily activities; Moderate Concern (20-27), indicating a moderate level of concern and worry about falling during activities; and High Concern (28-64), reflecting a high level of fear and anxiety about falling during activities.(18)
|
8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Balance
Time Frame: 8 weeks
|
Berg Balance Scale: The Berg Balance Scale is a widely used clinical tool to assess a person's static and dynamic balance abilities. It is a 14-item assessment scale that evaluates balance during various tasks. The Berg Balance scale is used to determine fall risk, predict length of stay in rehabilitation, and track progress in individuals with balance impairments (15) Cut-off scores for the elderly were reported by Berg et al. (1992). In this scale, a score of 56 indicates functional balance, a score of < 45 indicates a greater risk of falling, and a score of ≤ 49 indicates a risk of falls in individuals with stroke. (16) Studies of various elderly populations (N = 31-101, 60-90+ years of age) have shown high intra-rater and inter-rater reliability (ICC = .98, 14,15), a ratio of variability among subjects to total of .96-1.0 (16), and rs = .88 (17). Test-retest reliability in 22 people with hemiparesis is also high (ICC [2,1] = .98) (17) |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammad Hassan, Ms, 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/25/0220
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
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