Clinical trial NCT05738811: Effectiveness of EMS Versus TENS During Gait Training in Post Stroke Patients to Improve Gait and Quality of Life
Official title: Effectiveness of EMS Versus TENS During Gait Training in Post Stroke Patients to Improve Gait and Quality of Life A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Anterior Cerebral Artery
Lead sponsor: Sehat Medical Complex
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subacute Stroke Patients referred from neurophysician
* Anterior cerebral artery lesion
* Age between 40-70 years
* Well-oriented patients (ability to understand and follow simple verbal instructions)
* Ambulatory before stroke
* Ability to stand with or without assistance and to walk at least 10 meter with or without assistance

Exclusion Criteria:

* Red flags to walking or to electric stimulation
* History of peroneal nerve lesions
* Cognitive impairment
* Fixed plantar-flexor contractures
* Knee deformity

Primary outcomes:
measure: Wisconsin gait scale (change is being assessed)
timeFrame: Change from Baseline at 12 weeks
measure: 10 meter walk test (change is being assessed)
timeFrame: Change from Baseline at 12 weeks
measure: Stroke specific quality of life scale (change is being assessed)
timeFrame: Change from Baseline at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sehat Medical Complex, Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Zunaira Ahmad
role: PRINCIPAL_INVESTIGATOR
References: