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

August 26, 2023 updated by: Waseem Javaid, Sehat Medical Complex

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 55201
        • Sehat Medical Complex, Lahore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TENS treatment group
Group A was given exercise protocol along with TENS treatment protocol.
Other: TENS treatment protocol
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.
Other: Exercises
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.
Experimental: EMS treatment group
Group B received exercise protocol along with EMS treatment protocol.
Other: Exercises
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.
Other: EMS treatment protocol
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from Baseline at 12 weeks
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.
Change from Baseline at 12 weeks
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.
Change from Baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sehat Medical Complex

Investigators

  • Principal Investigator: Zunaira Ahmad, University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2023

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

August 24, 2023

Study Registration Dates

First Submitted

February 11, 2023

First Submitted That Met QC Criteria

February 11, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 26, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • zunairaahmad23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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