Clinical trial NCT02249832: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
CVA
cerebrovascular accident
cerebral stroke
robotic therapy
anklebot
physical therapy
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Comfortable Pace.
timeFrame: baseline, discharge (week 6), 3 month FU (overall week 18)
Secondary outcomes:
measure: Mean Change From Baseline in Gait Speed (m/Sec) on the 10 Meter Walk Test at Fast Pace.
timeFrame: baseline, discharge (week 6), 3 month FU (overall week 18)
measure: Mean Change From Baseline in Distance Walked (Meters) on the 6 Minute Walk Test at Comfortable Pace.
timeFrame: baseline, discharge (week 6), 3 month FU (overall week 18)
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institutes for Medical Research
state: New York
city: Manhasset
country: United States
facility: Transitions of Long Island Outpatient Rehabilitation
state: New York
Study officials:
References:
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.
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.
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.
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.