Effects of RR and MT on Patient With Stroke

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Detailed Description

Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Conditions

Interventions

  • Conventional rehabilitation Procedure
    Intervention Desc: Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
    ARM 1: Kind: Experimental
    Label: Conventional Rehabilitation
    Description: Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
  • Mirror therapy Other
    Intervention Desc: This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
    ARM 1: Kind: Experimental
    Label: Mirror Therapy
    Description: Mirror Therapy (MT)
  • Robotic Rehabilitation Behavioral
    Other Names: RR; Robotic Therapy; RT
    Intervention Desc: This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
    ARM 1: Kind: Experimental
    Label: Robotic Rehabilitation
    Description: Robotic Rehabilitation (RR)
  • Robotic rehabilitation with FES Behavioral
    Other Names: RR combined Functional Electrical Stimulation (RR-FES)
    Intervention Desc: This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
    ARM 1: Kind: Experimental
    Label: Robotic Rehabilitation with FES
    Description: Robotic rehabilitation combined Functional Electrical Stimulation (FES)
  • Robotic Rehabilitation with PI Behavioral
    Other Names: RR with Placebo Intervention (RR-PI)
    Intervention Desc: The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.
    ARM 1: Kind: Experimental
    Label: Robotic Rehabilitation with PI
    Description: Robotic rehabilitation with Placebo Intervention (RR-PI)

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Factorial Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment (FMA) Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks No
Primary Modified Ashworth Scale (MAS) Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks No
Primary Functional independence measure (FIM) Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks No
Primary Movement units (MU) Change from baseline in MU at 4 weeks No
Primary Total displacement (TD) Change from baseline in TD at 4 weeks No
Primary Percentage of peak velocity (PPV) Change from baseline in PPV at 4 weeks No
Primary Reaction time (RT) Change from baseline in RT at 4 weeks No
Primary Action Research Arm Test (ARAT) Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks No
Primary Medical Research Council scale (MRC) Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks No
Primary MYOTON-3 Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks No
Primary Accelerometers Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks No
Primary Peak velocity (PV) Change from baseline in PV at 4 weeks No
Primary Trunk related Kinematic variables Change from baseline in trunk related kinematic variables at 4 weeks No
Secondary Motor Activity Log (MAL) Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks No
Secondary ABILHAND Questionnaire Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks No
Secondary Stroke Impact Scale Version 3.0 (SIS 3.0) Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks No
Secondary Nottingham Extended Activities of Daily Living Scale (NEADL) Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks No
Secondary revised Nottingham Sensory Assessment (rNSA) Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks No
Secondary Fugl-Meyer Assessment-Sensory (FMA-S) Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks No
Secondary 8-OHdG: A Biomarker of Oxidative Stress Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks No
Secondary Multidimensional Fatigue Symptom Inventory (MFSI) Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks No

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