NCT00372411

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Dec 2005

Typical duration for phase_2 stroke

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

January 13, 2014

Completed
Last Updated

January 13, 2014

Status Verified

December 1, 2013

Enrollment Period

3.6 years

First QC Date

September 5, 2006

Results QC Date

September 4, 2013

Last Update Submit

December 18, 2013

Conditions

Stroke

Keywords

StrokeRehabilitationSingle-blindClinical TrialRandomized controlled trialUpper extremityRobotics

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment for Motor Recovery (FM) Scale

    Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.

    6, 12, 24 and 36 weeks minus baseline

Secondary Outcomes (4)

  • Stroke Impact Scale

    6, 12, 24 and 36 weeks minus baseline

  • Wolf Motor Function Test

    6, 12, 24 and 36 weeks minus baseline

  • Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline

    12 weeks minus baseline

  • Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline

    12 weeks minus baseline

Study Arms (3)

Arm 1

EXPERIMENTAL

Robot-Assisted Therapy - MIT-MANUS System

Device: Robot-Assisted Therapy - MIT-MANUS System

Arm 2

ACTIVE COMPARATOR

Intensive Comparison Therapy

Other: Intensive Comparison Therapy

Arm 3

OTHER

Usual Care

Other: Usual Care

Interventions

Robot-Assisted Therapy - MIT-MANUS SystemDEVICE

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
Intensive Comparison TherapyOTHER

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).

Also known as: ICT
Arm 2
Usual CareOTHER

The usual chronic stroke care as delivered at each participating medical center

Arm 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

Providence VA Medical Center

Providence, Rhode Island, 02908-4799, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (4)

  • 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.

    PMID: 19541917RESULT

  • 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.

    PMID: 20400552RESULT

  • 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.

    PMID: 21757677RESULT

  • 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.

    PMID: 28357039DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Peter Guarino, MPH, PhD, Director, WH-CSPCC
Organization
Dept. of Veterans Affairs, Cooperative Studies Program, West Haven, CT
peter.guarino@va.gov
203-932-5711

Study Officials

  • Albert Lo, MD PhD

    Providence VA Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2006

First Posted

September 7, 2006

Study Start

December 1, 2005

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

January 13, 2014

Results First Posted

January 13, 2014

Record last verified: 2013-12

Locations

US(5)