This single-blinded randomized controlled trial will be conducted at the Physical Therapy Department of the University of Lahore Teaching Hospital after approval from the Institute Research Ethics Board. Eligible participants will be recruited and randomly allocated into two groups by lottery method: Group A (control group) receiving conventional physical therapy, and Group B (experimental group) receiving neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction. NEMS will be applied to the tibialis anterior, extensor hallucis longus, and extensor digitorum longus with standard stimulation parameters, while participants perform active dorsiflexion during stimulation. The assessor will remain blinded to group allocation. Outcome measures including spasticity (Modified Ashworth Scale), active range of motion (goniometer), and muscle strength (manual muscle testing) will be evaluated at baseline, 6 weeks, and 12 weeks.
Recruitment: Participants will be recruited from Physical Therapy Department of University of Lahore Teaching Hospital, Lahore Screening: All the referred participants will be assessed for the eligibility criteria. Patients fulfilling the eligibility criteria will be asked to sign the consent forms before entering them to the study. Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group/NEMS + voluntary muscle contraction group. Group B: control group/standard rehabilitation therapy) by lottery method. Blinding: This study was a single blinded study in which assessor was kept blinded Intervention Group A: Comparative Group (Conventional physical therapy) Patients in comparative group will receive conventional approach that will encompass placebo effect application of NEMS, weight bearing , stretching , pnf technique , tapping , passive roms , strength exercise of dorsiflexors Group B : Experiment Group/NEMS+Voluntary muscle contraction group: The participants randomly allocated in Group A will receive the electrical stimulation through electrodes on tibialis anterior, extensor hallucis longus and extensor digitorum longus .Stimulation parameters will be as follows: pulse width=200 microseconds; on time=5seconds; off time=5seconds; frequency=20Hz; waveform=symmetrical biphasic square wave. The patient will be instructed to produce a voluntary dorsi flexors contraction with the electric pulse The stimulation intensity will adjusted according to each treatment group. All intensities were comfortable for the patients and did not induce fatigue. Any complaints and discomfort during the treatment process in each group will monitored and recorded using a patient record. Outcome Variables: 1. Spasticity: Modified Ashworth scale 2. Active rom: Goniometer 3. Muscle Grading: Manual muscle testing Data will be assessed by assessor at baseline, at the end of 6th week and at the end of 12th week
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
25
Conventional physiotherapy Participants in the comparative group will receive conventional physiotherapy treatment including placebo application of neuromuscular electrical stimulation (NEMS), weight-bearing exercises, stretching, proprioceptive neuromuscular facilitation (PNF) techniques, tapping, passive range of motion (PROM) exercises, and dorsiflexor strengthening exercises. The placebo NEMS will be applied in the same manner as the active stimulation but without any therapeutic current. Each session will be supervised by a physiotherapist. Treatment will be conducted as per the study protocol, and all participants' responses, complaints, and discomforts during the sessions will be monitored and recorded using a patient record sheet.
Experimental Group (NEMS + Voluntary Muscle Contraction) Neuromuscular Electrical Stimulation (NEMS) with Voluntary Muscle Contraction\<br\>\<br\>Participants in the experimental group will receive neuromuscular electrical stimulation (NEMS) combined with voluntary muscle contraction of the dorsiflexors. Surface electrodes will be placed over the tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles. Stimulation parameters will be set as follows: pulse width = 200 microseconds, on time = 5 seconds, off time = 5 seconds, frequency = 20 Hz, waveform = symmetrical biphasic square wave. Participants will be instructed to voluntarily contract the dorsiflexors during each stimulation pulse. The stimulation intensity will be adjusted according to patient comfort to avoid fatigue. Each session will be administered by a trained physiotherapist following the standardized protocol. Any discomfort or adverse response during the procedure will be documented in the patient.
University of lahore teaching hospital
Lahore, Punjab Province, Pakistan
Modified Ashworth scale
The Modified Ashworth Scale is a clinical tool used to assess muscle spasticity by measuring resistance during passive soft-tissue stretching. It grades the increase in muscle tone on a scale from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. It is a widely used and reliable method for evaluating the severity of spasticity in patients with neurological or musculoskeletal conditions.
Time frame: 12 weeks
Goniometery
A goniometer is an instrument that either measures an angle or allows an object to be rotated to a precise angular position.
Time frame: 12 weeks
Manual muscle testing
Manual Muscle Testing is a standardized clinical assessment used to evaluate the strength of individual muscles or muscle groups based on the examiner's application of resistance. Muscle strength is graded on a six-point scale (0-5), where 0 indicates no muscle contraction and 5 represents normal strength against full resistance. It is a reliable and widely used method to assess motor function, recovery, and the effectiveness of therapeutic interventions.
Time frame: 12 weeks
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