Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy

NCT04112173 | Terminated Results

• 2 other identifiers: 1490979-1U54GM104941
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic stroke is the leading cause of long-term disability in the United States. Post-stroke health is negatively impacted by two interrelated factors-a substantial risk of falls and limited walking activity. The risk of falling is a barrier to walking activity, with falls self-efficacy mediating the relationship between impaired physical capacity and limited activity. The ability to recover from a fall (i.e. arrest a fall before impact) is a logical, yet untested rehabilitation target to enable walking activity through sustained benefits to falls self-efficacy. Our aim is to demonstrate that fall-recovery training is feasible in stroke survivors with low falls self-efficacy. Five participants will undergo an adapted version of fall-recovery training. We will gather evidence of the implementation, adaptation, and limited efficacy of this intervention in affecting falls self-efficacy and walking activity.

Conditions

Stroke

Keywords

balance; self-efficacy; exercise; postural control

Outcome Measures

Primary Outcomes (4)

• Adverse Events Ending Participation

  The number of participants who end participation due to adverse events

  6 months

• Activities Specific Balance Confidence Questionnaire Score.

  Balance confidence, as measured by the Activities Specific Balance Confidence questionnaire. Scores range from 0 to 100, and represent the average rating of each question. Higher scores indicate more confidence. Range 0-100 Higher values represent a better outcome.

  6 months

• Falls Self-Efficacy Scale Score

  Falls Self-Efficacy, as measured by the Falls Self-Efficacy Scale. Scores are totaled, ranging from 16-64, with higher scores representing worse self-efficacy.

  6 months

• Walking Activity

  Average steps/day, as measured by a step monitor

  6 months

Secondary Outcomes (1)

• Stepping Threshold Assessment of Reactive Balance

  6 months

Study Arms (1)

Perturbation-Based Balance Training

EXPERIMENTAL

perturbation-based balance training

Behavioral: perturbation-based fall-recovery training

Interventions

perturbation-based fall-recovery training BEHAVIORAL

Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.

Also known as: balance training

Perturbation-Based Balance Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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, occurring six or more months prior to study enrollment.
• An Activities-Specific Balance Confidence (ABC) score less than 68.

You may not qualify if:

• More than one stroke
• Acute illness at the time of functional assessment or training
• Body mass greater than 136 kg (300 lbs) to ensure that the treadmill accelerates accurately
• 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

Sponsors & Collaborators

• University of Delaware: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19711, United States

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Limitations and Caveats

The study was halted due to the COVID-10 pandemic after one participant was enrolled and completed baseline assessments. The study did not resume and participation was terminated by the investigator.

Results Point of Contact

• Title: Jeremy Crenshaw, Ph.D.
• Organization: University of Delaware

crenshaw@udel.edu

302-831-4795

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Principal Investigator

Model Details: single-group, observational study

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 2, 2019
• Study Start: February 21, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: September 25, 2023
• Results First Posted: December 1, 2022

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)