Clinical trial NCT03638089: Fall Recovery Training for Individuals With Chronic Stroke
Official title: Fall Recovery Training for Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2018-08-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to quantify how fall-recovery training improves the fall-recovery response of individuals with chronic stroke. Up to 20 participants with chronic stroke will be recruited from the community. Over six laboratory visits, participants will undergo sessions of fall-recovery training. Each session is comprised of simulated trips and slips as participants stand on a computer-controlled treadmill. Trip-recovery training consists of treadmill-delivered disturbances that induce a forward fall. Slip-recovery training consists of a treadmill-delivered disturbances that induce a backward fall. Separate progressions focus on initial steps with the left and right limbs. The training intensity, as determined by the disturbance magnitude, is progressive and dependent on participant performance. Step length and maximum trunk angle will be calculated. The hypothesis is that, with practice, participants will recover from larger perturbations, and they will increase step length and reduce trunk rotation during fall recoveries.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18 years or older
* Participants must have had a single stroke of non-cerebellar origin

Exclusion Criteria:

* More than one stroke
* Unable to walk one block without stopping or using a walking aid, such as a cane
* Acute illness at the time of functional assessment or training
* Body mass greater than 136 kg (300 lbs)
* Lower extremity joint replacement or shoulder joint replacement within a year prior to participation
* Dementia
* Parkinson's disease
* A history of back surgery
* A history of neck surgery
* More than one occurrence of back or neck pain in the month prior to participation
* Current back or neck pain at the time of participant enrollment
* Bulging vertebral discs
* Spine, hip, or lower extremity fracture within a year prior to participation
* Open lesions on the lower extremity
* Insulin-dependent diabetes
* Use of a pacemaker
* Use of an ostomy pouch
* Pregnancy
* Osteoporosis
* Doctor recommendation to avoid moderate physical activity or exercise
* Any neural, muscular, or skeletal condition or injury that precludes safe participation in the training or introduces a confounding factor on the study, at the discretion of the clinician or study staff

Primary outcomes:
measure: Disturbance magnitude
timeFrame: 2-3 weeks (first to last training session)
Secondary outcomes:
measure: Step length
timeFrame: 2-3 weeks (first to last training session)
measure: Trunk rotation
timeFrame: 2-3 weeks (first to last training session)
Other outcomes:
Locations:
Study officials:
References:
citation: Pigman J, Reisman DS, Pohlig RT, Wright TR, Crenshaw JR. The development and feasibility of treadmill-induced fall recovery training applied to individuals with chronic stroke. BMC Neurol. 2019 May 25;19(1):102. doi: 10.1186/s12883-019-1320-8.