Effect of Soleus Muscle Kinetic Control Training on Gait and Electromyographic Activity in Patients With Stroke

NCT07309081 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/006089
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

this study was designed to investigate the effect of soleus muscle kinetic control training on Gait and electromyographic activity of the calf muscle in patients with stroke

Conditions

Stroke

Keywords

kinetic control; gait; EMG; stroke

Outcome Measures

Primary Outcomes (11)

• muscle amplitude

  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

  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 of gait cycle (seconds) will be measured by steady device

  up to eight weeks

• step time

  the time of step by seconds will be measured by steady device

  up to eight weeks

• cadence

  Cadence, number of steps per minute, will be measured by steady device

  up to eight weeks

• stance phase percentage

  the percentage of stance phase will be measured by steady device

  up to eight weeks

• swing phase percentage

  the percentage of swing phase will be measured by steady device

  up to eight weeks

• single and double support percentage

  single and double support percentage of gait cycle will be measured by steady device

  up to eight weeks

• first and second double support percentage

  first and second double support percentage of gait cycle will be measured by steady devcie

  up to eight weeks

• stride length

  stride length by cm will be measured by steady device

  up to eight weeks

• gait speed

  gait speed by km/h will measured by steady device

  up to eight weeks

Study Arms (2)

soleus kinetic control

EXPERIMENTAL

twenty patients will receive soleus kinetic control plus conventional physiotherapy three times a week for 8 weeks

Other: soleus kinetic control; Other: conventional therapy

conventional therapy

ACTIVE COMPARATOR

twenty patients will receive conventional physiotherapy three times a week for 8 weeks

Other: conventional therapy

Interventions

conventional therapy OTHER

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

conventional therapy; soleus kinetic control

soleus kinetic control OTHER

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.

soleus kinetic control

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

habiba mohamed, master

CONTACT

0 10 90708377; dochabiba4@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: opaque sealed envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator : habiba mohamed ahmed mahmoud

Model Details: kinetic and traditional therapy

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: December 30, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12