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Completed

NCT Number: NCT05738811

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

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.

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Key information

Conditions

Stroke, Anterior Cerebral Artery Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Infarction Infarction, Anterior Cerebral Artery Intracranial Arterial Diseases Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS treatment protocol

Other

The 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.

EMS treatment protocol

Other

The 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.

Exercises

Other

Patient 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.

Primary outcomes

  1. Wisconsin gait scale (change is being assessed)

    Time frame: Change from Baseline at 12 weeks

    Wisconsin Gait Scale is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.

    Minimum score is 13.35, highest the score, the more the gait is affected.

  2. 10 meter walk test (change is being assessed)

    Time frame: Change from Baseline at 12 weeks

    The individual is instructed to walk a set distance (6 meters, 10 meters, etc). Time is measured while the individual walks the set distance (often the individual is given space to accelerate to his/her preferred walking speed (this distance is not included when determining speed).

  3. Stroke specific quality of life scale (change is being assessed)

    Time frame: Change from Baseline at 12 weeks

    Specific Quality Of Life scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke. Scores range from 49-245. Higher scores indicate better functioning.

Sponsors and collaborators

Lead sponsor

Sehat Medical Complex

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 22, 2023
Registry last updated
Aug 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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