Clinical Trials Directory

Trials / Completed

CompletedNCT05738811

Effectiveness of EMS Versus TENS During Gait Training in Post Stroke Patients to Improve Gait and Quality of Life

Effectiveness of EMS Versus TENS During Gait Training in Post Stroke Patients to Improve Gait and Quality of Life A Randomized Clinical Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
38 (actual)
Sponsor
Sehat Medical Complex · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The goal of this Randomized clinical trial was to compare effectiveness of EMS versus TENS during gait training in stroke patients to improve gait and quality of life. The main question it aims to answer was: • To compare effectiveness of EMS versus TENS during gait training in post stroke survivors to improve gait and quality of life Participants were given consent form and after subjects read and sign the informed consent, they were included in study according to eligibility criteria. 2 groups were included in study, one group received stimulation through TENS and other through EMS. Both groups received exercise protocol and stimulation would be provided only during gait training. Outcome was measured through different outcome measure tools.

Detailed description

Patients with stroke experience gait disorders due to various causes, including sensory impairment and muscle weakness, spasticity, etc., and the primary goal of rehabilitation is to regain independent walking. The ankle plantar flexors tightly contract to maintain a standing posture and contribute to postural control through anticipatory contractions before changes in the center of mass. The plantar flexors in the ankle create most of the energy required for forward propulsion of body mass during walking. The strength of the ankle plantar flexors on the paretic side is related to the gait speed of patients with stroke. The peripheral sensory inputs via Electrical muscle stimulation enhanced the activities of circuits in the somatosensory cortex thus it can cause neuroplasticity to brain. Electrical stimulation on ankle dorsiflexors could be an effective management to enhance gait performance and ankle control during walking in chronic stroke patients. Neuromuscular electrical stimulation on ankle plantar flexors may improve gait symmetry. When neuromuscular stimulation combined with activity can enhance efficacy. Many previous studies conducted trials on effectiveness of muscle stimulation but this study aims to perform a clinical trial to enhance evidence about effectiveness. 2 groups were included in study, one group received stimulation through TENS and other through EMS. Both groups received exercise protocol and stimulation was provided only during gait training. The outcome was measured through different outcome measure tools. Functional electrical stimulation device was used to improve dorsiflexion during walking, but it was somehow expensive treatment. To achieve same outcome during walking, it is aimed to see effect of EMS vs TENS. This would be an inexpensive alternate of FES device and could improve gait and quality of life if used during treatment protocol. So it was aimed to generate evidence about effectiveness of TENS vs EMS on lower limb during gait training to improve gait and quality of life.

Conditions

Interventions

TypeNameDescription
OTHERTENS treatment protocolThe 2 sets of electrodes of TENS were placed over the common peroneal nerve as it passes over the head of fibula and the motor point of tibialis anterior to elicit dorsiflexion and eversion of foot.
OTHEREMS treatment protocolThe electrodes were placed over the common peroneal nerve as it passes over the head of fibula and the motor point of tibialis anterior to elicit dorsiflexion and eversion of foot. A portable comfy EMS channel was used to apply EMS protocol to set at threshold of muscle contraction level.
OTHERExercisesPatient were given 30 minutes treatment session, 10 minutes of supported walking 10 minutes of BWS treadmill training 10 minutes of Task-specific over ground locomotor training (LT) There was rest of 2 minutes The frequency of the sessions was five times a week for 12 weeks.

Timeline

Start date
2023-02-11
Primary completion
2023-06-30
Completion
2023-08-24
First posted
2023-02-22
Last updated
2023-08-29

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT05738811. Inclusion in this directory is not an endorsement.