Effectiveness of Neuromuscular Electrical Stimulation After Stroke

NCT03913624 | Completed DMC

• 1 other identifier: 43/09
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation; Electric stimulation; Upper limb; Aging

Outcome Measures

Primary Outcomes (4)

• Change in range of motion

  A universal goniometer was used to measure the resting angle, active extension and passive extension of the wrist. A special JAMAR finger goniometer was used to evaluate the resting angle and active extension of the metacarpophalangeal joints of the fingers.

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in dynamometric strength

  The grip strength was assessed by means of a JAMAR hydraulic hand dynamometer and the pinch strength using the JAMAR hydraulic pinch gauge. Unit of measurement was kgf. Three repetitions were done in both evaluations, taking the highest value and leaving a resting period of 1 minute between them.

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in muscle tone

  Hypertonia of the finger and wrist flexors was measured using the modified Ashworth scale (MAS). MAS was used to categorize the severity of muscle tone by judging resistance to passive movement. It is a 6-point scale (0, 1, 1+ 2, 3, and 4) that ranges from 1 (=no increase in tone) to 4 (=limb rigid in flexion or extension). The assessment was started 5 minutes after laying the subject down in the supine position and using a single passive movement to evaluate each muscle group.

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in functional motor ability

  Manual dexterity was assessed by Box and block test.

  The groups were assessed at baseline and 12 weeks post-intervention.

Secondary Outcomes (6)

• Change in the mean electromyographic (EMG) amplitude

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in the peak EMG amplitude

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in the antagonist co-activation ratio

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in kinaesthetic sensation

  The groups were assessed at baseline and 12 weeks post-intervention.

• Change in activities of daily living

  The groups were assessed at baseline and 12 weeks post-intervention.

Other Outcomes (1)

• Intervention costs

  Intervention costs were recorded from the baseline to 12 weeks.

Study Arms (3)

50 Hz NMES group

EXPERIMENTAL

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.

Other: Neuromuscular electrical stimulation

35 Hz NMES group

EXPERIMENTAL

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.

Other: Neuromuscular electrical stimulation

Control group

NO INTERVENTION

Conventional treatment

Interventions

Neuromuscular electrical stimulation OTHER

35 Hz NMES group; 50 Hz NMES group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Doctor Peset University Hospital

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Trinidad Sentandreu Mañó, PT, PhD

  University of Valencia

  PRINCIPAL INVESTIGATOR

• J. Ricardo Salom Terrádez, MD, PhD

  Doctor Peset University Hospital

  STUDY CHAIR

• J. Manuel Tomas, PhD

  University of Valencia

  STUDY CHAIR

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: Principal Investigator

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: April 12, 2019
• Study Start: July 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

ES (1)