Clinical trial NCT00372411: Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Official title: CSP #558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Single-blind
Clinical Trial
Randomized controlled trial
Upper extremity
Robotics
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Burke Medical Research Institute
First posted: 2006-09-07
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
* Age 18 years of age and older.
* Upper extremity Fugl-Meyer score \>=7 or \<=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
* Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
* Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
* Written informed consent to participate in the study.

Exclusion Criteria:

* A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
* Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
* Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
* Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
* A complicating medical condition that would prevent completion of the trial.
* Unable to complete the nine-month study, e.g., extended planned vacation.
* Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.

Primary outcomes:
measure: Fugl-Meyer Assessment for Motor Recovery (FM) Scale
timeFrame: 6, 12, 24 and 36 weeks minus baseline
Secondary outcomes:
measure: Stroke Impact Scale
timeFrame: 6, 12, 24 and 36 weeks minus baseline
measure: Wolf Motor Function Test
timeFrame: 6, 12, 24 and 36 weeks minus baseline
measure: Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline
timeFrame: 12 weeks minus baseline
measure: Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline
timeFrame: 12 weeks minus baseline
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Health Care System (West Haven)
state: Connecticut
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Baltimore
country: United States
facility: VA Maryland Health Care System, Baltimore
state: Maryland
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
city: Seattle
country: United States
facility: VA Puget Sound Health Care System, Seattle
state: Washington
Study officials:
affiliation: Providence VA Medical Center
name: Albert Lo, MD PhD
role: STUDY_CHAIR
References:
citation: Lo AC, Guarino P, Krebs HI, Volpe BT, Bever CT, Duncan PW, Ringer RJ, Wagner TH, Richards LG, Bravata DM, Haselkorn JK, Wittenberg GF, Federman DG, Corn BH, Maffucci AD, Peduzzi P. Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. Neurorehabil Neural Repair. 2009 Oct;23(8):775-83. doi: 10.1177/1545968309338195. Epub 2009 Jun 18.
citation: Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
citation: Wagner TH, Lo AC, Peduzzi P, Bravata DM, Huang GD, Krebs HI, Ringer RJ, Federman DG, Richards LG, Haselkorn JK, Wittenberg GF, Volpe BT, Bever CT, Duncan PW, Siroka A, Guarino PD. An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke. Stroke. 2011 Sep;42(9):2630-2. doi: 10.1161/STROKEAHA.110.606442. Epub 2011 Jul 14.
citation: Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016.