Trial Outcomes & Findings for Fall-recovery Training for Those With Chronic Stroke and Low Falls Self-efficacy (NCT NCT04112173)

NCT ID: NCT04112173

Last Updated: 2023-09-25

Results Overview

The number of participants who end participation due to adverse events

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

6 months

Results posted on

2023-09-25

Participant Flow

One participant recruited on 2/21/2020 at University of Delaware campus.

Participant milestones

Participant milestones
Measure
Perturbation-based Balance Training
perturbation-based balance training perturbation-based fall-recovery training: 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.
Overall Study
STARTED
1
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Perturbation-based Balance Training
perturbation-based balance training perturbation-based fall-recovery training: 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.
Overall Study
Study terminated due to COVID-19 pandemic
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=1 Participants
perturbation-based balance training perturbation-based fall-recovery training: 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.
Age, Continuous
56 years
n=99 Participants
Sex: Female, Male
Female
0 Participants
n=99 Participants
Sex: Female, Male
Male
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
Race (NIH/OMB)
White
1 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Balance Confidence
52 units on a scale
n=99 Participants
Lower Extremity Fugl-Meyer
20 units on a scale
n=99 Participants
Stroke Impact Scale
Strength
12.5 units on a scale
n=99 Participants
Stroke Impact Scale
Memory and Thinking
83.3 units on a scale
n=99 Participants
Stroke Impact Scale
Emotions
83.3 units on a scale
n=99 Participants
Stroke Impact Scale
Communication
64.3 units on a scale
n=99 Participants
Stroke Impact Scale
ADL/IADL
70 units on a scale
n=99 Participants
Stroke Impact Scale
Mobility
66.7 units on a scale
n=99 Participants
Stroke Impact Scale
Hand Function
0 units on a scale
n=99 Participants
Stroke Impact Scale
Participation/Role
68.8 units on a scale
n=99 Participants
Anteroposterior stepping thresholds
Anterior
1 m/s^2
n=99 Participants
Anteroposterior stepping thresholds
Posterior
2.5 m/s^2
n=99 Participants
Falls Efficacy Scale
38 units on a scale
n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.

The number of participants who end participation due to adverse events

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.

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.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 6 months

Population: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.

Average steps/day, as measured by a step monitor

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: The study was terminated prior to reaching the pre-specified time frame for recording this data. This outcome measure was not recorded.

Stepping thresholds are the treadmill-induced, standing perturbation magnitudes that elicit anterior, posterior, or lateral steps. These thresholds are determined from a series of progressively challenging perturbations, delivered as participants stand on a computer-controlled treadmill. The thresholds are the size of the perturbation (measured as acceleration) that results in a step for four trial. Participants are instructed to try not to step. One progression consists of forward and backward perturbations to determine anterior and posterior thresholds. A second progression is done with participants facing the side of the treadmill, with the progression identifying left and right stepping thresholds. Anterior, posterior, left, and right thresholds are considered independently (i.e. not averaged or summed).

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Crenshaw, Ph.D.

University of Delaware

Phone: 302-831-4795

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place