The General Use of Robots in Stroke Recovery: the Anklebot

NCT02249832 | Completed Results

• 1 other identifier: 13-310
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)).

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

seated robot-assisted ankle therapy

EXPERIMENTAL

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.

Device: seated robot-assisted ankle therapy

Interventions

seated robot-assisted ankle therapy 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.

Also known as: Massachusetts Insititute of Technology (MIT) Anklebot

seated robot-assisted ankle therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (2)

Feinstein Institutes for Medical Research

Manhasset, New York, 11030, United States

Location

Transitions of Long Island Outpatient Rehabilitation

Manhasset, New York, 11030, United States

Location

Related Publications (4)

• 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.

  PMID: 20492698 BACKGROUND

• 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.

  PMID: 21346215 BACKGROUND

• 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.

  PMID: 21115945 BACKGROUND

• 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.

  PMID: 24515923 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Bruce T. Volpe, MD
• Organization: Feinstein Institutes for Medical Research

bvolpe1@northwell.edu

(516) 562-3384

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 26, 2014
• Study Start: June 1, 2013
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: March 9, 2021
• Results First Posted: November 15, 2019

Record last verified: 2019-11

Locations

US (2)