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

NCT ID: NCT05738811

Last Updated: 2023-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-11

Study Completion Date

2023-08-24

Brief Summary

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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

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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

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Stroke, Anterior Cerebral Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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TENS treatment group

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

Group Type EXPERIMENTAL

TENS treatment protocol

Intervention Type 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.

Exercises

Intervention Type 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.

EMS treatment group

Group B received exercise protocol along with EMS treatment protocol.

Group Type EXPERIMENTAL

EMS treatment protocol

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sehat Medical Complex

OTHER

Sponsor Role lead

Responsible Party

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Waseem Javaid

Project Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zunaira Ahmad

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

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Sehat Medical Complex, Lahore

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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zunairaahmad23

Identifier Type: -

Identifier Source: org_study_id

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