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

NCT05738811 | Completed

• 1 other identifier: zunairaahmad23
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Anterior Cerebral Artery

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from Baseline at 12 weeks

• 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).

  Change from Baseline at 12 weeks

• 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.

  Change from Baseline at 12 weeks

Study Arms (2)

TENS treatment group

EXPERIMENTAL

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

Other: TENS treatment protocol; Other: Exercises

EMS treatment group

EXPERIMENTAL

Group B received exercise protocol along with EMS treatment protocol.

Other: EMS treatment protocol; Other: Exercises

Interventions

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.

TENS treatment group

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.

EMS treatment group

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.

EMS treatment group; TENS treatment group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sehat Medical Complex: lead

Study Sites (1)

Sehat Medical Complex, Lahore

Lahore, Punjab Province, 55201, Pakistan

Location

MeSH Terms

Conditions

Infarction, Anterior Cerebral Artery

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zunaira Ahmad

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Director

Study Record Dates

• First Submitted: February 11, 2023
• First Posted: February 22, 2023
• Study Start: February 11, 2023
• Primary Completion: June 30, 2023
• Study Completion: August 24, 2023
• Last Updated: August 29, 2023

Record last verified: 2023-08

Locations

PA (1)