Effects of Neuromuscular Electrical Stimulation on Individuals With Chronic Stroke in Patients With Chronic Stroke

Summary

Stroke is commonly associated with increased spasticity that affects patients' function and increased risk of fall. Interventional approaches have been used to decrease spasticity including pharmacological and non-pharmacological interventions. However, Limited research has examined non-pharmacological interventions such as neuromuscular electric stimulation (NMES) on spasticity and health outcomes in people with stroke. So, The primary purpose of this study is to establish a protocol for a randomized clinical trial to examine using NMES on spasticity, muscle strength, physical functions, and self-reported health outcomes in people with chronic stroke in Saudi Arabia.

This randomized clinical trial will be double blinded for both participants and assessors to enroll 40 participants with chronic stroke to either interventional group or control shame group. The intervention will be 3 times a week for 4 weeks for both groups. Outcomes will include calf muscle spasticity, pretibial muscle strength, ankle range of motion, gait speed, balance, functional mobility, walking endurance, and self-reported health measures such as quality of life, physical activity, fatigue, and risk of fall. Independent t-test will be utilized to examine the effect of intervention on change score means for outcome measures. Using 4 weeks of NMES will provide information about its effect in improving spasticity, physical functions, and other self-reported health outcomes in people with chronic stroke when compared to control shame NMES.

We assume this electrical stimulation will reduce leg muscle spasticity and improve muscle strength. Therefore, this study will help individuals with chronic stoke in improve walking function, balance, and quality of life.

Conditions

• Chronic Stroke

Interventions

DEVICE

Active Electrical stimulation

The intensity of stimulation will be set within the subject's tolerance level. The amplitude was adjusted to produce muscle contraction without affecting the patient's comfort. The cathode electrode will be placed over the common peroneal nerve as it passes over the head of the fibula and the anode will be placed on mid-muscle belly on one third of the line between fibular head and medial malleolus on paretic limb.

DEVICE

Sham Electrical Stimulation

For sham group, the current intensity will gradually decreased after few seconds to 0. Therefore, the participant will experience a passage of current on the muscle at the beginning but received no current for the rest of the stimulation period. The participants will be informed that the stimulation below the sensory level.

Sponsors & Collaborators

• Qassim University

  lead OTHER

Principal Investigators

• Sattam Almutairi, Ph.D · Qassim University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-02

Primary Completion

2023-06-30

Completion

2023-06-30

Countries

• Saudi Arabia

Study Locations