Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients "VA ROBOTICS"

Completed

Phase 2 Results

Trial Description

This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.

Detailed Description

Primary Hypothesis: The primary hypothesis is that robotic training compared with usual care and intensive comparison therapy will lead to improved upper extremity function. Eligible patients will be randomized to one of three treatment arms: 1) usual care, 2) intensive comparison therapy, or 3) robotic training. Participants assigned to intensive comparison therapy or robot-assisted training will receive treatment for 12 weeks consisting of three one-hour sessions a week and then usual care for the remainder of follow-up. Those assigned to usual care will receive the usual stroke care as delivered at each participating medical center for 36 weeks and then will be offered, as compassionate care, their choice of either robot-assisted or intensive comparison therapy.
Secondary Hypothesis: The secondary hypotheses are that compared with usual care and intensive comparison therapy, robotic treatment will lead to improved quality of life and task performance involving proximal and distal control of the paretic arm. If the robotic arm is effective, two other secondary objects are to evaluate its early (less than 12 week) and late (36 week) effects on the primary and secondary outcomes.
Primary Outcome: The primary study outcome is the change in the Fugl-Meyer score of neurological impairment at 12 weeks relative to baseline.
Secondary Outcome: Secondary outcomes include the Stroke Impact Scale and Wolf Motor Function Test. A cost-effectiveness analysis is planned but only will be conducted if robotic training is more effective than usual care.
Study Abstract: CSP #558 will be a randomized, multi-center, outpatient phase II trial to assess the safety and efficacy of robot-assisted therapy for neurorehabilitation in stroke patients with moderate to severe upper extremity impairment.
The target sample is 158 patients: 26 usual care, 66 intensive comparison therapy and 66 robot training. This sample size will provide 90% power to detect a 5-point mean difference in the Fugl-Meyer scale between robot training and usual care and 3-point mean difference between robot training and intensive comparison therapy. There will be one interim analysis of the primary endpoint at 12 months for the purpose of sample size re-estimation using an adaptive design. The planned study duration is 33 months with 24 months of intake and nine months of follow-up.
IMPACT STATEMENT
If robotic training proves to be beneficial it will not only provide a functionally-oriented and neurophysiologically appropriate therapy, but also will make more widely available high-quality, evidence-based rehabilitative care at a time when there is a shortage of experienced therapists and a progressively growing rehabilitative need for veterans and all Americans.

Conditions

Interventions

  • MIT-MANUS Behavioral
    Intervention Desc: A robotic system for physical therapy and neurological rehabilitation. The robot provides adjustable levels of guidance and assistance to facilitate the person's movement using a computer system.
  • Usual care Other
    Intervention Desc: The usual chronic stroke care as delivered at each participating medical center
    ARM 1: Kind: Experimental
    Label: Arm 3
    Description: Usual Care
  • Robot-Assisted Therapy - MIT-MANUS System Device
    Intervention Desc: The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.
    ARM 1: Kind: Experimental
    Label: 1
    Description: MIT-MANUS System (Robot)
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: MIT-MANUS System (Robot)
  • Intensive Comparison Therapy Other
    Other Names: ICT
    Intervention Desc: The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).
    ARM 1: Kind: Experimental
    Label: 2
    Description: Intensive Comparison Therapy
    ARM 2: Kind: Experimental
    Label: Arm 2
    Description: Intensive Comparison Therapy

Trial Design

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

Patient Involvement

Patients will have Fugl-Meyer Assessment for Motor Recovery Scale and MMSE at baseline. Eligible patients will be randomized to one of three treatment arms: 1) usual care, 2) intensive comparison therapy, or 3) robotic training. Participants assigned to intensive comparison therapy or robot-assisted training will receive treatment for 12 weeks consisting of three one-hour sessions a week and then usual care for the remainder of follow-up. Those assigned to usual care will receive the usual stroke care as delivered at each participating medical center for 36 weeks and then will be offered, as compassionate care, their choice of either robot-assisted or intensive comparison therapy. The planned study duration is 33 months with 24 months of intake and nine months of follow-up. FM Scale will be repeated at follow-up.

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Assessment for Motor Recovery (FM) Scale
Secondary Stroke Impact Scale 12 weeks No
Secondary Wolf Motor Function Test 12 weeks No
Secondary Numeric Rating Scale (NRS) 12 weeks Yes
Secondary Modified Ashworth Scale for spasticity. 12 weeks Yes
Secondary Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline 12 weeks minus baseline Yes
Secondary Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline 12 weeks minus baseline Yes

Sponsors