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

NCT04673045 | Unknown

• 1 other identifier: 10126-fcohsb-2020-1-3-I
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Modified Ashworth Scale (MAS) at baseline and 4 weeks

  The spastic plantarflexor muscles tone will be measured on affected leg by using MAS. Spasticity will be graded according to MAS which is a 6-point rating scale with scores ranging from 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension) for ankle dorsiflexor (Charalambous, 2014). Participants will be placed in a supine position. To test ankle plantarflexor muscles' spasticity, from maximal ankle plantarflexor position, passively move the ankle to maximal dorsiflexion position over one second. The test will be performed at the baseline and post the intervention.

  Change from baseline spastic plantarflexor muscles tone in affected leg at 4 weeks.

• Active and Passive Range of Motion at baseline and 4 weeks

  The evaluation tests consisted of passive and active ankle joint ROM. The measurement will be in degrees using a handheld goniometer. Goniometry was performed with the subject in supine position with extended knees, and the measurement was made at the neutral position between dorsal flexion and plantar flexion. The axis of the goniometer will be placed 2 cm below the medial malleolus, and its moving axis will be placed along the first metatarsal bone. The passive ROM was determined as the range that the experimenter was able to move the subject's ankle beginning in maximum plantarflexion, to maximum dorsiflexion until any resistance was felt. Similarly the active ROM was measured by asking the participants to move joints maximally. The test will be performed at the baseline and post the intervention. The average of three measurements will be calculated and the result will be the dorsiflexion ROM.

  Change from baseline of active and passive range of motion in affected ankle joint at 4 weeks.

• Manual Muscle Test for Ankle Dorsiflexors at baseline and 4 weeks

  Ankle dorsiflexion is an important kinematic aspect of the swing and initial stance phase of the gait cycle. In clinical practice, muscle strength is most often evaluated using manual muscle strength testing using the Medical Research Council (MRC) grade. The ankle dorsiflexor strength will be graded according to the MMT; graded from 0 (no contraction at all) to 5 (full range of movement against power and the same force as on the opposite side) for ankle dorsiflexor. The test will be performed at the baseline and post the intervention.

  Change from baseline ankle dorsiflexors in affected leg at 4 weeks.

• 10-Meter Walk Test (10MWT) at baseline and 4 weeks

  The 10MWT assesses self-selected preferred walking speed over a short duration with or without an assistive device. The participant will be asked to walk a total of 10 meters where an acceleration zone is used for the participants to accelerate 2 meters before entering the 6-meter distance and 2 meters to decelerate afterwards. Speed is only calculated for the 6m distance between the end zones. The 10MWT is widely used in clinical practice and in research for people with stroke and has been shown to have an excellent test-retest reliability (ICC \> 0.95) (Collen, Wade, \& Bradshaw, 1990). The minimally clinically important difference (MCID) is reported as 0.14 m/s for substantial meaningful change (Perera, Mody, Woodman, \& Studenski, 2006). The test will be performed three times and the resulting speeds obtained will be averaged. The test will be performed at the baseline and post the intervention.

  Change from baseline gait velocity at 4 weeks.

• Timed Up and Go at baseline and 4 weeks

  Timed Up-and-Go (TUG) test will be used to measure the walking time. The TUG assesses functional mobility by assessing an individual's ability to stand up, walk 3 meters at a comfortable pace, turn 180 degrees, walk 3 meters, and sit down (Shumway-Cook, Brauer, \& Woollacott, 2000). The TUG test has been shown the excellent reliability and validity in stroke population and the minimal detectable change (MDC) is 2.9 seconds (Flansbjer, Holmback, Downham, Patten, \& Lexell, 2005). Two practice trials of the TUG will be allowed to familiarize the participant with the task. TUG is a valid method for screening of functional mobility and risk for falls in community-dwelling elderly people(Shumway-Cook et al., 2000).

  Change from baseline mobility at 4 weeks.

Secondary Outcomes (7)

• Fall Efficacy Scale International (FES-I) at baseline and 4 weeks

  Change from baseline balance at 4 weeks.

• Rapid Assessment of Physical Activity (RAPA) at baseline and 4 weeks

  Change from baseline physical activity at 4 weeks.

• Patient Health Questionnaire-9 at baseline and 4 weeks

  Change from baseline depression at 4 weeks.

• Fatigue Severity Scale (FSS) at baseline and 4 weeks

  Change from baseline fatigue at 4 weeks.

• Quality of life (Short Form 36) at baseline and 4 weeks

  Change from baseline quality of life at 4 weeks.

Study Arms (2)

Active neuromuscular electrical stimulation

ACTIVE COMPARATOR

This group will receive active NMES delivered the electrical current through electrodes inserted in saline-soaked sponges.

Device: Active Electrical stimulation

Sham neuromuscular electrical stimulation

SHAM COMPARATOR

This group will receive sham NMES

Device: Sham Electrical Stimulation

Interventions

Active Electrical stimulation DEVICE

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.

Also known as: GymnaUniphy NV / COMBI 400

Active neuromuscular electrical stimulation

Sham Electrical Stimulation DEVICE

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.

Also known as: GymnaUniphy NV / COMBI 400

Sham neuromuscular electrical stimulation

Eligibility Criteria

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

You may qualify if:

• Hemiparesis due to stroke; at least 6 months since stroke
• Independent ambulatory ability with or without assistive device at least 10 meters
• Spasticity on ankle dorsiflexors ≥ 2 on Modified Ashworth Scale (MAS) (Charalambous, 2014)
• Functional ambulation ≥ 3 on functional ambulation categories (Mehrholz, Wagner, Rutte, Meiβner, \& Pohl, 2007)

You may not qualify if:

• Skin integrity issues on contact surface of NMES
• Significant cognitive impairments (unable to follow 3 step commands),
• Other serious medical conditions
• History of other neurologic or orthopedic disorder affecting walking function
• More than one previous stroke
• Contraindications to NMES, such as a pacemaker or tumor
• Injected with any medicine that reduce spasticity

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

King Fahad Specialist Hospital

Buraidah, Saudi Arabia

RECRUITING

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Study Officials

• Sattam Almutairi, Ph.D

  Qassim University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sattam Almutairi, Ph.D

CONTACT

966505102644; A.Sattam@qu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 17, 2020
• Study Start: February 2, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Locations

SA (1)