N/A N=62 Randomized Single-blind Treatment

A Novel Strategy to Decrease Fall Incidence Post-Stroke

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02688777 ↗

Enrolled (actual)

Serious AEs

29.0%

Results posted

Nov 2023

Primary outcome: Primary: Fall Incidence (Number of Falls) — 88; 56 number of falls

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Backward Walking Training (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Fall Incidence (Number of Falls)	88; 56	—
SECONDARY 10 Meter Walk Test	0.17; 0.22	0.37
SECONDARY 3-Meter Backward Walk Test	0.13; 0.19	0.13
SECONDARY Functional Gait Assessment	4.8; 5.6	0.40
SECONDARY Activities-Specific Balance Confidence Scale	15.9; 21.6	0.12
SECONDARY Berg Balance Scale	10.1; 10.4	0.43
SECONDARY Lower-Extremity Fugl-Meyer Motor Score	2.6; 4.8	0.02 sig
SECONDARY Four-Step Square Test	20.54; 34.49	0.28
SECONDARY Stride Time	0.30; 0.26	0.22
SECONDARY Stride Length	5.1; 6.1	0.10
SECONDARY Step Time	.116; .195	0.09
SECONDARY Step Length	3.4; 5.0	0.11
SECONDARY Step Width	1.2; 2.2	0.28

Summary

Approximately 15,000 Veterans are hospitalized for stroke each year with new cases costing an estimated $111 million for acute inpatient, $75 million for post-acute inpatient, and $88 million for follow-up care over 6 months post-stroke. Contributing to these costs is the incidence of falls. Falls are a costly complication for Veterans with stroke as they lead to an increased incidence of fractures, depression, and mortality. New strategies are needed to help Veterans post-stroke regain their ability to safely walk without increasing their risk of falling as well as readily identify those who are a fall risk. This study addresses both of these needs as it will 1) investigate a new treatment approach, backward walking training, to determine if it will decrease fall incidence in the first year post-stroke and 2) determine if backward walking speed early after a stroke can identify those that are at risk for future falls.

Eligibility Criteria

Inclusion Criteria

Berg Balance Scale 2 months 25
ankle plantar flexion contracture > 15
Severe hypertension with systolic greater than 200 mmHg and diastolic greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg
Pain upon ambulation
Receiving physical therapy services for mobility and/or gait
Living in a skilled nursing facility
Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking less than 200 meters
History of serious chronic obstructive pulmonary disease or oxygen independence
Non-healing ulcers on the lower extremity
Uncontrollable diabetes with recent weight loss, diabetic coma or frequent insulin reactions
On renal dialysis or presence of end stage liver disease
Pulmonary embolism within previous 6 months
History of major head trauma
History of sustained alcoholism or drug abuse in the last six months
Intracranial hemorrhage related to aneurysmal rupture or an arteriovenous malformation
Current enrollment in a clinical trial to enhance stroke motor recovery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02688777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.