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

Primary Purpose

Stroke, Anterior Cerebral Artery

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
TENS treatment protocol
EMS treatment protocol
Exercises
Sponsored by
Sehat Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Anterior Cerebral Artery

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sehat Medical Complex, Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

TENS treatment group

EMS treatment group

Arm Description

Group A was given exercise protocol along with TENS treatment protocol.

Group B received exercise protocol along with EMS treatment protocol.

Outcomes

Primary Outcome Measures

Wisconsin gait scale (change is being assessed)
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.
10 meter walk test (change is being assessed)
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).
Stroke specific quality of life scale (change is being assessed)
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.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2023
Last Updated
August 26, 2023
Sponsor
Sehat Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT05738811
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 11, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
August 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Anterior Cerebral Artery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS treatment group
Arm Type
Experimental
Arm Description
Group A was given exercise protocol along with TENS treatment protocol.
Arm Title
EMS treatment group
Arm Type
Experimental
Arm Description
Group B received exercise protocol along with EMS treatment protocol.
Intervention Type
Other
Intervention Name(s)
TENS treatment protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EMS treatment protocol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
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 Outcome Measure Information:
Title
Wisconsin gait scale (change is being assessed)
Description
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.
Time Frame
Change from Baseline at 12 weeks
Title
10 meter walk test (change is being assessed)
Description
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).
Time Frame
Change from Baseline at 12 weeks
Title
Stroke specific quality of life scale (change is being assessed)
Description
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.
Time Frame
Change from Baseline at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zunaira Ahmad
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat Medical Complex, Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
55201
Country
Pakistan

12. IPD Sharing Statement

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

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