NCT03578250

Brief Summary

Post-stroke individuals continue to suffer from significant motor impairments years after the stroke. Motor recovery is usually limited to the first 6 month after the stroke, in which the majority of improvements occur at the first three months. Error augmentation (EA) training using a robotic apparatus was suggested to enhance motor recovery by exploiting the adaptation mechanisms within the intact cerebellum in individuals who sustained cortical stroke. The aim of this study is to investigate whether error augmentation training for the upper extremity may enhance motor recovery in individuals that sustained cortical stroke. Fifty post-stroke individuals will be randomaly assigned into either EA training (study group- SG) or robotic training in null field environment (control group- CG). Both groups will carry out the same treatment protocol on the robotic device in addition to the standard rehabilitation protocol of the rehabilitation center. Treatment protocol will be consisted of about six training sessions on the robotic device, taken twice or three times a week for two to three weeks. Each training session will be composed of 20-30 minutes upper extremity training with or without EA force field. Motor performance will be evaluated before and after the treatment protocol by the Fugl-Meyer Assessment scale.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

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, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

June 25, 2018

Last Update Submit

June 25, 2018

Conditions

Stroke

Keywords

StrokeError augmentationRehabilitationCerebellumMotor learningAdaptation

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Scale

    Clinical test for the assessment of motor impairments of the upper extremity

    Baseline

Study Arms (2)

Study Group

EXPERIMENTAL

Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device. During training the robotic device will apply error augmentation force-field to perturbate the arm of the participant away from the straight trajectory line.

Other: Robotic Training

Control group

EXPERIMENTAL

Training of the upper extremity on a robotic device. Participants will carry out hand reaching movement for multiple directions in 3 dimensions, while grasping the robotic handle according to assignments given by the robotic device. During training the robotic device will not apply any perturbations on the participant's arm.

Other: Robotic Training

Interventions

Robotic TrainingOTHER

Upper extremity training on a robotic device with or without error augmentation force field.

Control groupStudy Group

Eligibility Criteria

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

You may qualify if:

  • Cortical stroke, unilateral hemiparesis

You may not qualify if:

  • other neurological disorders (Alzheimer's disease, PD), complete plegia,unilateral neglect,sensory aphasia, Mini Mental State Examination\<20

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bait Balev

Nesher, Israel

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Eli Carmeli, PhD

    Professor

    STUDY DIRECTOR

Central Study Contacts

Eli Carmeli, PhD

CONTACT

972-04-8288397ecarmeli@univ.haifa.ac.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2018

First Posted

July 6, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

July 6, 2018

Record last verified: 2018-06

Locations

IL(1)