Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07458750
Brief Summary:
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.
Detailed Description:
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:
NCT07458750
Study Brief:
Protocol Section:
NCT07458750