NCT03599544

Brief Summary

This study evaluates the effects of robot-assisted therapy for adults more than 6 months after stroke on upper limb functioning. Half of the participants will receive robot-assisted therapy for the arm affected by stroke, and the other half will receive robot-assisted therapy plus training in how to use the weaker arm during every day activities.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

June 6, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2020

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

9 months

First QC Date

July 16, 2018

Last Update Submit

November 28, 2023

Conditions

StrokeCerebrovascular Accident

Keywords

Upper limb functionArm and hand weakness

Outcome Measures

Primary Outcomes (6)

  • Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks

    The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.

    Baseline and 6 weeks

  • Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 6 weeks

    The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.

    Baseline and 6 weeks

  • Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 6 weeks

    The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.

    Baseline and 6 weeks

  • Change from Baseline Fugl-Meyer Assessment (FMA) at 10 weeks

    The Fugl-Meyer Assessment (FMA) will examine changes in motor function in the paretic upper extremity (UE) during basic reaching and grasping motions. All items are rated by a 3-point ordinal scale (0=cannot perform; 2=performs fully) with a total possible score of 60 points (reflex items will not be administered). Higher scores indicate better performance.

    Baseline and 10 weeks

  • Change from Baseline Motor Activity Log (MAL) Amount of Use (AOU) at 10 weeks

    The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.

    Baseline and 10 weeks

  • Change from Baseline Motor Activity Log (MAL) Quality of Movement (QOM) at 10 weeks

    The Motor Activity Log (MAL) is a self-report measure in which the person is asked to rate their use of the paretic arm and hand during 28 daily activities. Two scales are used for scoring: Amount of Use (AOU) and Quality of Movement (QOM). Scores range from 0 to 5 (0=not used at all, 5=as well as before stroke) and the average score for each scale is used to assess upper limb function. Higher scores indicate better performance.

    Baseline and 10 weeks

Secondary Outcomes (16)

  • Change from Baseline Modified Ashworth Scale (MAS) at 6 weeks

    Baseline and 6 weeks

  • Change from Baseline Wolf Motor Function Test (WMFT) Time at 6 weeks

    Baseline and 6 weeks

  • Change from Baseline Wolf Motor Function Test (WMFT) Strength (kg) at 6 weeks

    Baseline and 6 weeks

  • Change from Baseline Wolf Motor Function Test (WMFT) Functional Ability Score (FAS) at 6 weeks

    Baseline and 6 weeks

  • Change from Baseline Canadian Occupational Performance Measure (COPM) at 6 weeks

    Baseline and 6 weeks

  • +11 more secondary outcomes

Study Arms (2)

Robot-Assisted Therapy (RT)

ACTIVE COMPARATOR

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks.

Behavioral: Robot-Assisted Therapy (RT)

Robot + Active Learning Program(RT-ALPS)

EXPERIMENTAL

Armeo \& Amadeo robot-assisted intensive upper limb therapy 1 hour sessions 3x week for 6 weeks plus training in active problem solving, analysis of performance, and goal-setting focused on the transfer of acquired motor skills to daily activities in the home and community.

Behavioral: Robot + Active Learning Program(RT-ALPS)

Interventions

Robot-Assisted Therapy (RT)BEHAVIORAL

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks).

Robot-Assisted Therapy (RT)
Robot + Active Learning Program(RT-ALPS)BEHAVIORAL

Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks). In addition, participants will receive training in active problem solving, analysis of performance and goal setting focused on home action plan activities to assist with carry-over and generalization to every day activities.

Robot + Active Learning Program(RT-ALPS)

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with unilateral stroke more than 6 months prior to study enrollment.
  • Stroke type will include both ischemic and hemorrhagic stroke.
  • Moderate UE hemiparesis (characterized by initial scores on upper limb subtest of the Fugl-Meyer Assessment (FMA) between 19-47/60)
  • Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score \>/=26/30)during the initial evaluation visit

You may not qualify if:

  • No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy, as indicated by subtests of the Fugl-Meyer Assessment (FMA) \[13\]
  • Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale \[15\];
  • Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test \[16\]
  • Aphasia sufficient to limit comprehension and completion of the treatment protocol
  • Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
  • Treatment with Botox injections for the affected arm within the previous 4 months or planned Botox injections before the end of the study
  • Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

MGH Institute of Health Professions

Boston, Massachusetts, 02129, United States

Location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Paolo Bonato, PhD

    Spaulding Rehabilitation Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Evaluator(s) will be blinded to assigned study group and intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MGH Institute of Health Professions

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 26, 2018

Study Start

June 6, 2019

Primary Completion

March 3, 2020

Study Completion

March 3, 2020

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)