The General Use of Robots in Stroke Recovery: the Anklebot | NCT02249832

The General Use of Robots in Stroke Recovery: the Anklebot | NCT02249832 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)).

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Feinstein Institutes for Medical Research		Manhasset	New York	11030	United States
Transitions of Long Island Outpatient Rehabilitation

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20492698	Background	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.
21346215	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.

ID	Title	Description
FG000	Seated Robotic Ankle Therapy	Participants received eighteen 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00055 subjects
COMPLETED		FG00042 subjects
NOT COMPLETED		FG00013 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0003 subjects
Lost to Follow-up		FG00010 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Seated Robotic Ankle Therapy	Participants received eighteen, 1 hour sessions (3 times/week for 6 weeks) of seated anklebot training with the MIT Anklebot.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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)).

Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.

Posted

Mean

Standard Error

m/sec

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

ID	Title	Description
OG000	Low Gait Speed Group

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Seated Robotic Ankle Therapy	All participants received eighteen 1 hour sessions (3x/week for 6 weeks) of seated anklebot training with the MIT anklebot. Prior to the intervention, subjects were initially stratified based on average admission gait speed on the 10 Meter Walk Test at comfortable pace according to well standardized and accepted gait speed performance levels: low (<0.4m/sec), moderate (0.4m/sec-0.8m/sec) and high (>0.8m/sec) functioning, in order to determine if there were impairment-level differences in the recovery pattern following ankle training.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
worsening baseline ankle pain	Musculoskeletal and connective tissue disorders		Non-systematic Assessment

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
neuropathic pain	Nervous system disorders		Non-systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Bruce T. Volpe, MD	Feinstein Institutes for Medical Research	(516) 562-3384		bvolpe1@northwell.edu

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 31, 2016	Sep 19, 2019	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	May 31, 2016	Feb 17, 2021	ICF_001.pdf

Condition Browse Module

ID	Term
D020521	Stroke

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0008
Native Hawaiian or Other Pacific Islander	BG0000
Black or African American	BG0006
White	BG00040
More than one race	BG0001
Unknown or Not Reported	BG0000

Title

Denominators

Categories

Mean gait speed at baseline

Title	Measurements
	OG0000.22± 0.02 OG0010.53± 0.03 OG0021.02± 0.07

Mean gait speed at discharge (week 6)

Title	Measurements
	OG0000.26± 0.02 OG0010.62± 0.04 OG0021.18± 0.12

Mean gait speed at 3month FU (overall week 18)

Title	Measurements
	OG0000.24± 0.02 OG0010.66± 0.04 OG0021.29± 0.10

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		ANOVA		<0.001	A significance level of 0.05 was used (two-sided).													Equivalence	A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).

Secondary

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)).

Subjects were stratified according to clinically established gait speed impairment levels based on average admission gait speed on the 10 Meter Walk Test at comfortable pace.

Posted

Mean

Standard Error

m/sec

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

ID	Title	Description
OG000	Low Gait Speed Group	The low gait speed group included all subjects with a mean gait speed of <0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.
OG001	Moderate Gait Speed Group	The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.
OG002	High Gait Speed Group	The high gait speed group included all subjects with a mean gait speed of >0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed impairment levels.

Units	Counts
Participants	OG00021 OG00114 OG0027

Title

Denominators

Categories

mean gait speed at baseline

Title	Measurements
	OG0000.25± 0.02 OG0010.67± 0.06 OG0021.30± 0.13

mean gait speed at discharge (week 6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002	A 3x3 repeated measures ANOVA was performed with group (mean gait speed in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).	ANOVA		<0.001														Equivalence	A significance level of 0.05 was used (two-sided).

Secondary

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)).

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 levels.

Posted

Mean

Standard Error

meters

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

ID	Title	Description
OG000	Low Gait Speed Group	The low gait speed group included all subjects with a mean gait speed of <0.4m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
OG001	Moderate Gait Speed Group	The moderate gait speed group included all subjects with a mean gait speed of 0.4-0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.
OG002	High Gait Speed Group	The high gait speed group included all subjects with a mean gait speed of >0.8m/sec on the admission 10 Meter Walk Test at comfortable pace, based upon clinically established gait speed performance levels.

Units	Counts
Participants	OG00021 OG00114 OG0027

Title

Denominators

Categories

mean distance at baseline

Title	Measurements
	OG00068.46± 5.76 OG001152.92± 9.53 OG002280.43± 19.19

mean distance at discharge (week 6)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		ANOVA		0.001	A significance level of 0.05 was used (two-sided).													Equivalence	A 3x3 repeated measures ANOVA was performed with group (mean distance walked in the low, moderate, and high groups) and time (admission, discharge (week 6), and follow-up (overall week 18) in each condition) as factors. Null hypothesis was that there was no difference in mean gait speed over time across the three groups. A significance level of 0.05 was used (two-sided).