Clinical trial NCT04673045: Effects of Neuromuscular Electrical Stimulation on Individuals With Chronic Stroke in Patients With Chronic Stroke
Official title: Effects of Neuromuscular Electrical Stimulation on Walking Ability and Quality of Life in Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Assignment of intervention:

Allocation sequence generation: The participants will be randomly allocated to either a EG or a NMESsham. The randomization process will be generated by an independent research assistant who is not involved in the treatment or data collection using online randomization website (https://www.graphpad.com/quickcalcs/randomize1.cfm).

Allocation concealment: All randomized allocations of participants will be placed in a sealed envelope for each participant. A research assistant will prepare envelopes and withholds information from assessors and participants. After completing the baseline assessment, a research assistant will inform the training therapist who is not involved in the study about the patients' allocation.

Blinding: In this double-blind study, the assessors and patients will be blinded to groups' allocation. Assessors will be banned from attending interventional sessions for both groups, and participant's allocation will be managed in schedules to minimize contact between participants in both groups.

After the inform consent, participants will complete an intake form or demographic data (age, sex, occupation), past medical history, past surgical history and activity level. Additionally, they will be screened for inclusion/exclusion criteria. Participants who meet the inclusion/exclusion criteria will be evaluated on the main outcomes prior and post to the intervention. The participants will be randomized into 2 groups.

All participants will receive conventional rehabilitation program (CRP) including warming up, strengthening, stretching exercise, gait training for 45 minutes per a day for three times a week for four weeks. In addition, EG will receive 30 minutes active NMES and the control group will receive 30 minutes NMESSham. The NMES delivered the electrical current through electrodes inserted in saline-soaked sponges. 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. For NMESsham group, electrode sponges will be placed at the same position as the active NMES condition; however, 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.

The pre- and post-training assessments will be completed within 3 days before and after the training sessions. Assessment data will be obtained by another physical therapist who blind to the group assignment.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Modified Ashworth Scale (MAS) at baseline and 4 weeks
timeFrame: Change from baseline spastic plantarflexor muscles tone in affected leg at 4 weeks.
measure: Active and Passive Range of Motion at baseline and 4 weeks
timeFrame: Change from baseline of active and passive range of motion in affected ankle joint at 4 weeks.
measure: Manual Muscle Test for Ankle Dorsiflexors at baseline and 4 weeks
timeFrame: Change from baseline ankle dorsiflexors in affected leg at 4 weeks.
measure: 10-Meter Walk Test (10MWT) at baseline and 4 weeks
timeFrame: Change from baseline gait velocity at 4 weeks.
measure: Timed Up and Go at baseline and 4 weeks
timeFrame: Change from baseline mobility at 4 weeks.
Secondary outcomes:
measure: Fall Efficacy Scale International (FES-I) at baseline and 4 weeks
timeFrame: Change from baseline balance at 4 weeks.
measure: Rapid Assessment of Physical Activity (RAPA) at baseline and 4 weeks
timeFrame: Change from baseline physical activity at 4 weeks.
measure: Patient Health Questionnaire-9 at baseline and 4 weeks
timeFrame: Change from baseline depression at 4 weeks.
measure: Fatigue Severity Scale (FSS) at baseline and 4 weeks
timeFrame: Change from baseline fatigue at 4 weeks.
measure: Quality of life (Short Form 36) at baseline and 4 weeks
timeFrame: Change from baseline quality of life at 4 weeks.
measure: Six Minute Walk Test at baseline and 4 weeks
timeFrame: Change from baseline endurance at 4 weeks.
measure: The Barthel index (BI) at baseline and 4 weeks
timeFrame: Change from baseline activities of daily living at 4 weeks.
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: King Fahad Specialist Hospital
Study officials:
affiliation: Qassim University
name: Sattam Almutairi, Ph.D
role: PRINCIPAL_INVESTIGATOR
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