The General Use of Robots in Stroke Recovery: the Anklebot

NCT ID: NCT02249832

Last Updated: 2021-03-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study is to determine if isolated robot-assisted training of the ankle joint improves chronic hemiparetic gait in patients after stroke.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects received 18 sessions (3 times per week for 6 weeks) of seated robotic ankle training. Upon analysis, subjects were stratified by average admission gait speed on the 10 Meter Walk Test at comfortable pace, according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) gait functioning.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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seated robot-assisted ankle therapy

All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated robot-assisted ankle training with the MIT anklebot. Upon analysis, subjects were stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to clinically established gait speed performance groups: low (\<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (\>0.8m/sec) functioning.

Group Type EXPERIMENTAL

seated robot-assisted ankle therapy

Intervention Type DEVICE

The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.

Interventions

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seated robot-assisted ankle therapy

The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.

Intervention Type DEVICE

Other Intervention Names

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Massachusetts Insititute of Technology (MIT) Anklebot

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
* Cognitive function sufficient enough to understand experiments and follow instructions
* Some amount of independent ambulation (with orthoses or walker)

Exclusion Criteria

* Botox treatment within 6-weeks of enrollment;
* Fixed contraction deformity in the affected limb;
* Complete and total flaccid paralysis of all lower extremity motor function;
* Unable to ambulate except with the aid of another person
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Bruce Volpe

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Feinstein Institutes for Medical Research

Manhasset, New York, United States

Site Status

Transitions of Long Island Outpatient Rehabilitation

Manhasset, New York, United States

Site Status

Countries

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United States

References

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Khanna I, Roy A, Rodgers MM, Krebs HI, Macko RM, Forrester LW. Effects of unilateral robotic limb loading on gait characteristics in subjects with chronic stroke. J Neuroeng Rehabil. 2010 May 21;7:23. doi: 10.1186/1743-0003-7-23.

Reference Type BACKGROUND
PMID: 20492698 (View on PubMed)

Roy A, Krebs HI, Bever CT, Forrester LW, Macko RF, Hogan N. Measurement of passive ankle stiffness in subjects with chronic hemiparesis using a novel ankle robot. J Neurophysiol. 2011 May;105(5):2132-49. doi: 10.1152/jn.01014.2010. Epub 2011 Feb 23.

Reference Type BACKGROUND
PMID: 21346215 (View on PubMed)

Forrester LW, Roy A, Krebs HI, Macko RF. Ankle training with a robotic device improves hemiparetic gait after a stroke. Neurorehabil Neural Repair. 2011 May;25(4):369-77. doi: 10.1177/1545968310388291. Epub 2010 Nov 29.

Reference Type BACKGROUND
PMID: 21115945 (View on PubMed)

Forrester LW, Roy A, Krywonis A, Kehs G, Krebs HI, Macko RF. Modular ankle robotics training in early subacute stroke: a randomized controlled pilot study. Neurorehabil Neural Repair. 2014 Sep;28(7):678-87. doi: 10.1177/1545968314521004. Epub 2014 Feb 10.

Reference Type BACKGROUND
PMID: 24515923 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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13-310

Identifier Type: -

Identifier Source: org_study_id

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