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The General Use of Robots in Stroke Recovery: the Anklebot

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

seated robot-assisted ankle therapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, CVA, cerebrovascular accident, cerebral stroke, robotic therapy, anklebot, physical therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Feinstein Institutes for Medical Research
Transitions of Long Island Outpatient Rehabilitation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

seated robot-assisted ankle therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.

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. Mean gait speeds on the 10m Walk Test at comfortable pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).

Secondary Outcome Measures

Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.

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. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).

Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.

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. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).

Full Information

NCT ID

NCT02249832

First Posted

September 23, 2014

Last Updated

February 17, 2021

Sponsor

Northwell Health

1. Study Identification

Unique Protocol Identification Number

NCT02249832

Brief Title

The General Use of Robots in Stroke Recovery: the Anklebot

Official Title

The General Use of Robots in Stroke Recovery: the Anklebot

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

February 2019 (Actual)

Study Completion Date

May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwell Health

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke, CVA, cerebrovascular accident, cerebral stroke, robotic therapy, anklebot, physical therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

seated robot-assisted ankle therapy

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

seated robot-assisted ankle therapy

Other Intervention Name(s)

Massachusetts Insititute of Technology (MIT) Anklebot

Intervention Description

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.

Primary Outcome Measure Information:

Title

Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.

Description

Time Frame

baseline, discharge (week 6), 3 month FU (overall week 18)

Secondary Outcome Measure Information:

Title

Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.

Description

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. Mean gait speeds on the 10m Walk Test at fast pace (m/sec) were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).

Time Frame

baseline, discharge (week 6), 3 month FU (overall week 18)

Title

Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.

Description

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. Mean distance walked (m) on the 6 Minute Walk test at comfortable pace were then compared across these three groups (low, moderate, and high function) at three timepoints (baseline, discharge (week 6), and 3 month FU (overall week 18)).

Time Frame

baseline, discharge (week 6), 3 month FU (overall week 18)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Feinstein Institutes for Medical Research

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Transitions of Long Island Outpatient Rehabilitation

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

20492698

Citation

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.

Results Reference

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PubMed Identifier

21346215

Citation

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.

Results Reference

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PubMed Identifier

21115945

Citation

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.

Results Reference

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PubMed Identifier

24515923

Citation

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.

Results Reference

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The General Use of Robots in Stroke Recovery: the Anklebot

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