Effectiveness of Neuromuscular Electrical Stimulation After Stroke

NCT ID: NCT03913624

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-09-30

Brief Summary

A Randomized Clinical Trial (RCT) was conducted to determine the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor recovery in older adults with spastic hemiparesis after a stroke.

Detailed Description

Impairment of the upper limb is one of the most frequent consequences of stroke and directly impacts on the patient's functional status and quality of life. It is estimated that less than 50% of stroke survivors will recover arm function, which will exert a great economic, social and personal toll.

Neuromuscular electrical stimulation (NMES) is one of the techniques suggested for upper limb recovery in stroke patients. However, after considering the bibliographic background, more studies are required in order to test its effectiveness, to establish the most efficient NMES protocols and to assess the characteristics of the patients who can benefit the most from this treatment. With this regard, the parameters of the stimulation are currently subject to debate, and more data are needed to optimize the application of this treatment. The aim of this study was to evaluate and compare the effects of two neuromuscular electrical stimulation protocols with different stimulation frequencies on motor impairment, kinaesthetic sensation, functional motor ability, activities of daily living, and quality of life in older adults with spastic hemiparesis suffering a stroke.

To cope with the objective of the present study, RCT was conducted. Subjects who met inclusion criteria were recruited from a hospital rehabilitation unit. After the screening and signed consent, participants were randomly allocated to the control group or one of both experimental groups. NMES was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The electrostimulation protocols were only differentiated in the parameter of the stimulation frequency, 35 Hz or 50 Hz, depending on the experimental group to which the patient belonged to. Outcome measures were collected at the beginning, after 4 and 8 weeks of treatment, and after a follow-up period (4 weeks).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

50 Hz NMES group

Neuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 50 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs.

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: OTHER

35 Hz NMES group

Neuromuscular electrical stimulation (NMES) was applied on wrist and finger extensors for 30 minutes, 3 sessions per week for 8 weeks. The main electrostimulation parameters consisted of low-frequency current, a stimulation frequency of 35 Hz, symmetrical rectangular biphasic wave, and pulse duration of 300 μs.

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation

Intervention Type: OTHER

Control group

Conventional treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neuromuscular electrical stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 60 years
• Post-stroke spastic hemiparesis
• Mild-moderate hand impairment
• A score ≤ 3 on the modified Ashworth scale for wrist and finger flexors
• Active wrist extension ≥ 5º from the resting position
• Wrist extension response to stimulation
• Post-stroke period < 18 months
• Clinical stability
• Mini-Mental State Examination score ≥ 23

Exclusion Criteria

• Previous hemiparesis due to stroke
• Dermatological reactions with the application of stimulation
• Significant sensory deficits in the affected arm
• Previous musculoskeletal problems of the hand
• Treatment with the botulin toxin
• Anti-spastic medication usage
• Cardiac pacemaker, implanted electronic device, or metal implants in the affected arm
• Complex regional pain syndrome
• Severe aphasia, history of epileptic seizures, psychiatric disorder or important alterations of behavior
• Severe visual impairment
• Any comorbid neurological disease
• Important deformity or obesity that affects the application of the NMES
• Potentially fatal cardiac arrhythmia or another decompensated heart disease
• Systemic infectious process, cancer or another terminal disease

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Trinidad Sentandreu-Mañó

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trinidad Sentandreu Mañó, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

J. Ricardo Salom Terrádez, MD, PhD

Role: STUDY_CHAIR

Doctor Peset University Hospital

J. Manuel Tomas, PhD

Role: STUDY_CHAIR

University of Valencia

Locations

Doctor Peset University Hospital

Valencia, , Spain

Countries

Spain

Other Identifiers

43/09

Identifier Type: -

Identifier Source: org_study_id