NCT03638089

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

August 16, 2018

Last Update Submit

September 16, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Step length

    2-3 weeks (first to last training session)

  • Trunk rotation

    2-3 weeks (first to last training session)

Study Arms (1)

Intervention Group

EXPERIMENTAL

This group will receive up to six sessions of fall-recovery training over the course of 2-3 weeks.

Behavioral: Fall-recovery training

Interventions

Participants practice recovering from simulated, treadmill-induced slips and trips.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

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
Assistant Professor

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

September 11, 2015

Primary Completion

July 7, 2019

Study Completion

July 7, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share