35 Hz Versus 50 Hz Frequency Stimulation Effects on Motor Recovery in Older Adults After Stroke. A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Change in dynamometric strength
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Neuromuscular electrical stimulation (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.
Intervention: Neuromuscular electrical stimulation (Other)
Control group
Conventional treatment
Outcomes
Primary Outcomes
Change in dynamometric strength
Time Frame: The groups were assessed at baseline and 12 weeks post-intervention.
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.
Change in muscle tone
Time Frame: The groups were assessed at baseline and 12 weeks post-intervention.
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.
Change in functional motor ability
Time Frame: The groups were assessed at baseline and 12 weeks post-intervention.
Manual dexterity was assessed by Box and block test.
Change in range of motion
Time Frame: The groups were assessed at baseline and 12 weeks post-intervention.
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.
Secondary Outcomes
- Change in the peak EMG amplitude(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.)
- Change in the mean electromyographic (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 health-related quality of life(The groups were assessed at baseline and 12 weeks post-intervention.)
Investigators
Trinidad Sentandreu-Mañó
Principal Investigator
University of Valencia