Post Stroke Hand Functions: Bilateral Movements and Electrical Stimulation Treatments

Completed

Phase 2 Results

Trial Description

The purpose of this study was to determine the effect of two amounts of treatment therapy on post stroke motor recovery in the arms. The therapy is bilateral movement training combined with electrical stimulation on the impaired limb.

Detailed Description

Intense movement training (practice) with the affected arm after stroke has the potential to improve upper extremity (UE) function resulting from neuroplasticity changes in the motor cortex. However, the necessary and sufficient parameters of this therapy in humans have not been fully investigated. Delineation of the most efficacious and efficient therapy for promoting UE recovery post-stroke is necessary before effective clinical implementation of this therapy. The current compared the effects on motor function impairments for three bilateral movement groups involving two doses of treatment (i.e., bilateral training coupled with neuromuscular electrical stimulation) and a sham control. During the subacute recovery phase (3 - 6 months), patients who meet motor capabilities criteria will be randomly assigned to one of three groups: (a) low intensity: 90 minutes/session, 2 sessions/week 2 weeks; bilateral movement training coupled with active neuromuscular stimulation on the impaired wrist/fingers; (b) high intensity: 90 minutes/session, 4 sessions/week for 2 weeks; bilateral movement training coupled with active stimulation on the impaired wrist/finger extensors; and (c) control group (sham active stimulation). Patients' UE motor capabilities were assessed before treatment therapy began (pretest) and within the first week after the treatment therapy ended (posttest).

Conditions

Interventions

  • Bilateral movement practice + neuromuscular electrical stimulation Behavioral
    Other Names: functional electrical stimulation
    Intervention Desc: Participants practice moving their paretic arm at the same time as they move their non-paretic arm in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the motion
    ARM 1: Kind: Experimental
    Label: High Intensity
    Description: Bilateral practice moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
  • Bilateral motor practice + neuromuscular electrical stimulation Behavioral
    Other Names: functional electrical stimulation
    Intervention Desc: Participants will practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own muscle contractions are provided to the paretic arm during the movements.
    ARM 1: Kind: Experimental
    Label: low intensity
    Description: bilateral practice moving the arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
  • Sham electrical stimulation + bilateral motor practice Behavioral
    Other Names: functional electrical stimulation - sham
    Intervention Desc: Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement
    ARM 1: Kind: Experimental
    Label: Control
    Description: Bilateral motor practice coupled with sham neuromuscular electrical stimulation
  • Bilateral movements and neuromuscular electrical stimulation Behavioral
    Other Names: functional electrical stimulation
    Intervention Desc: Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Neuromuscular electrical stimulation triggered by the participants' own contracting muscles is provided to the paretic arm during the movements. Training period was 2 times per week for 2 weeks.
    ARM 1: Kind: Experimental
    Label: High Intensity
    Description: Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
    ARM 2: Kind: Experimental
    Label: Low Intensity
    Description: Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
  • Bilateral movements and sham electrical stimulation Behavioral
    Other Names: functional electrical stimulation - sham
    Intervention Desc: Participants practice moving both their paretic and non-paretic arms at the same time in the same movement patterns. Sham electrical stimulation (low level electrical stimulation that can be felt but is insufficient to trigger a muscle contraction) is provided to the paretic arm during the movement. Training period was 2 times per week for 2 weeks.
    ARM 1: Kind: Experimental
    Label: Control
    Description: Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity Motor Test 2 weeks No
Primary Box and Block Test 2 weeks No
Primary Wolf Motor Function Test 2 weeks No
Primary Fractionated Reaction Time and Sustained Muscle Contraction 2 weeks No
Primary Box and Block Test; Data Collected = Number of Blocks Moved Baseline/pretest; 2 weeks treatment; posttest No
Primary Fractionated Reaction Time Baseline/pretest; 2 weeks treatment; posttest No

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