Fall Recovery Training for Individuals With Chronic Stroke

Stroke Clinical Trial

Official title:

Fall Recovery Training for Individuals With Chronic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638089
• Other study ID #: 791562-8
• Status: Completed
• Phase: N/A
• Start date: September 11, 2015
• Est. completion date: July 7, 2019

Study information

• Verified date: September 2019
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 7, 2019
• Est. primary completion date: July 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Fall-recovery training
Participants practice recovering from simulated, treadmill-induced slips and trips.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Delaware

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disturbance magnitude	The highest disturbance magnitude from which a successful fall-recovery resulted on the first and last training sessions	2-3 weeks (first to last training session)
Secondary	Step length	The length of the initial recovery step in response to the highest disturbance magnitude common to the first and last training sessions	2-3 weeks (first to last training session)
Secondary	Trunk rotation	The maximum trunk rotation angle in response to the highest disturbance magnitude common to the first and last training sessions	2-3 weeks (first to last training session)