- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309081
Effect of Soleus Muscle Kinetic Control Training on Gait and Electromyographic Activity in Patients With Stroke (EMG)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: habiba mohamed, master
- Phone Number: 0 10 90708377
- Email: dochabiba4@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ischemic or hemorrhagic stroke, as confirmed by CT and or MRI scan.
- Age of the patients between 45 to 60 years old.
- Ability to walk a minimum of 10 m with or without some physical assistance from a therapist (functional ambulation category more than 2).
- Demonstrate weakness of the foot muscles, measured by muscle function tests according Medical Research council scale more than 3.
- Muscle tone of the affected lower limb ranges from 1 to +1 according to modified Ashworth scale.
Exclusion Criteria:
- Unilateral neglect, hemianopia, or apraxia
- Having any other neurological disorder affecting their lower extremities e.g. MS, Parkinsonism, peripheral neuropathy.
- Patients with previous fractures in lower limb (Ankle or foot).
- Patients with musculoskeletal disorder such as severe arthritis, ankle surgery, leg length discrepancy or contractures of fixed deformity of ankle joint.
- Patients with visual, auditory impairment affecting their ability to complete tasks.
- Patients with cognitive impairments
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: soleus kinetic control
twenty patients will receive soleus kinetic control plus conventional physiotherapy three times a week for 8 weeks
|
patients will receive kinetic control for 30 minutes structural progressive training for the soleus muscle guided by the EMG biofeedback plus conventional therapy; 1)Start in crook lying position with the heels level with the pelvis and lift the pelvis clear of the floor followed by bilateral heel raise,2)Progress further by shifting weight onto one leg and holding the heel raise and slowly lowering eccentrically on 1 foot, the next progression is to perform the same movement with the heels lower than the pelvis on step -below the pelvis.
The exercise graduation will be guided by the visual EMG Biofeedback participants will receive feedback on soleus activation throughout the training.
the patients will receives conventional physiotherapy program static stretching and stretching board for calf muscle, stretching board, and push off exercises by having the patient push against the therapist or a treatment table during forward gait ( 30 minute), static stretch(30sec\set , rest 20sec\set total 5 set, 3 times \week , for 8 week ), stretching board (4 min\set , rest 1 min\set total 2 set , 3 times \week , for 8 week ) (10 minute) push off training (15 minute 3 times \week , for 8 week )x2
|
|
Active Comparator: conventional therapy
twenty patients will receive conventional physiotherapy three times a week for 8 weeks
|
the patients will receives conventional physiotherapy program static stretching and stretching board for calf muscle, stretching board, and push off exercises by having the patient push against the therapist or a treatment table during forward gait ( 30 minute), static stretch(30sec\set , rest 20sec\set total 5 set, 3 times \week , for 8 week ), stretching board (4 min\set , rest 1 min\set total 2 set , 3 times \week , for 8 week ) (10 minute) push off training (15 minute 3 times \week , for 8 week )x2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle amplitude
Time Frame: up to eight weeks
|
A steady device will be used to assess muscle amplitude in the form of RMS with microvolt as the measurement unit
|
up to eight weeks
|
|
giat function
Time Frame: up to eight weeks
|
The Dynamic Gait Index (DGI) is an ordinal test of gait function evaluates the capacity to adapt gait to complex walking tasks encountered in everyday life. Eight aspects of gait are scored based on observation as the patient walks over a 6.1-m level surface. The rater records an ordinal score that ranges from 0 (unable or done very poorly) to 3 (normal score) for a total point value of 24. Scores of less than 21 appear to suggest risk for falls |
up to eight weeks
|
|
Gait Cycle time
Time Frame: up to eight weeks
|
time of gait cycle (seconds) will be measured by steady device
|
up to eight weeks
|
|
step time
Time Frame: up to eight weeks
|
the time of step by seconds will be measured by steady device
|
up to eight weeks
|
|
cadence
Time Frame: up to eight weeks
|
Cadence, number of steps per minute, will be measured by steady device
|
up to eight weeks
|
|
stance phase percentage
Time Frame: up to eight weeks
|
the percentage of stance phase will be measured by steady device
|
up to eight weeks
|
|
swing phase percentage
Time Frame: up to eight weeks
|
the percentage of swing phase will be measured by steady device
|
up to eight weeks
|
|
single and double support percentage
Time Frame: up to eight weeks
|
single and double support percentage of gait cycle will be measured by steady device
|
up to eight weeks
|
|
first and second double support percentage
Time Frame: up to eight weeks
|
first and second double support percentage of gait cycle will be measured by steady devcie
|
up to eight weeks
|
|
stride length
Time Frame: up to eight weeks
|
stride length by cm will be measured by steady device
|
up to eight weeks
|
|
gait speed
Time Frame: up to eight weeks
|
gait speed by km/h will measured by steady device
|
up to eight weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006089
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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