NCT00453843

Brief Summary

We will test on persons with chronic impairment due to stroke:

  1. 1.whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
  2. 2.whether we should train the shoulder, elbow, and wrist at the same time or on different days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for phase_2 stroke

Timeline
Completed

Started Jun 2004

Longer than P75 for phase_2 stroke

Geographic Reach
1 country

1 active site

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

June 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 30, 2012

Status Verified

March 1, 2007

Enrollment Period

6.5 years

First QC Date

March 27, 2007

Last Update Submit

October 28, 2012

Conditions

Stroke

Keywords

Strokemovement therapyroboticsrehabilitation roboticsshoulder, elbow, wrist

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer

    3 times at baseline, midpoint, completion intervention, and at follow-up

  • Motor Power

    3 times at baseline, midpoint, completion intervention, and at follow-up

Secondary Outcomes (2)

  • Wolf Motor Function

    3 times at baseline, midpoint, completion intervention, and at follow-up

  • SIS

    3 times at baseline, midpoint, completion intervention, and at follow-up

Study Arms (4)

proximal to distal training

EXPERIMENTAL
Device: rehabilitation roboticsProcedure: Movement therapy

distal to proximal

EXPERIMENTAL
Device: rehabilitation roboticsProcedure: Movement therapy

proximal and distal on alternate days

EXPERIMENTAL
Device: rehabilitation roboticsProcedure: Movement therapy

proximal and distal same day

EXPERIMENTAL
Device: rehabilitation roboticsProcedure: Movement therapy

Interventions

rehabilitation roboticsDEVICE

sequence of intervention

Also known as: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
distal to proximalproximal and distal on alternate daysproximal and distal same dayproximal to distal training
Movement therapyPROCEDURE

sequence of intervention

Also known as: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
distal to proximalproximal and distal on alternate daysproximal and distal same dayproximal to distal training

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients will be included in the study if they meet the following criteria:
  • naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
  • first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
  • cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
  • average Motor Power score \>= 1/5 or \<= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
  • informed written consent to participate in the study.

You may not qualify if:

  • Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hermano I Krebs, PhD

    Massachusetts Institute of Technology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 27, 2007

First Posted

March 29, 2007

Study Start

June 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 30, 2012

Record last verified: 2007-03

Locations

US(1)