Trial Outcomes & Findings for Reactive Balance Training Targeting Both Slip- and Trip-Induced Falls (NCT NCT04308239)

NCT ID: NCT04308239

Last Updated: 2020-05-18

Results Overview

highest instantaneous speed of slipping foot during actual slip

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: during week 1, before the intervention that spanned weeks 2 and 3
• Results posted on: 2020-05-18

Participant Flow

Participant milestones

Measure	Reactive Balance Training Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Training in each session was 30 minutes for each participant. Reactive balance training involved both slip and trip training. Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis. Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial.	Control Balance Training Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). Otago Balance Training: Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
Pre-intervention Evaluation (1 Week) STARTED	20	14
Pre-intervention Evaluation (1 Week) COMPLETED	17	11
Pre-intervention Evaluation (1 Week) NOT COMPLETED	3	3
Intervention (2 Weeks) STARTED	20	14
Intervention (2 Weeks) COMPLETED	20	14
Intervention (2 Weeks) NOT COMPLETED	0	0
Post-intervention Evaluation (1 Week) STARTED	20	14
Post-intervention Evaluation (1 Week) COMPLETED	19	10
Post-intervention Evaluation (1 Week) NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Reactive Balance Training Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Training in each session was 30 minutes for each participant. Reactive balance training involved both slip and trip training. Slip training involved repeatedly stepping onto a low-friction interface (nylon fabric placed over a 0.9 × 0.9 meter polycarbonate sheet) while practicing controlling/decelerating the slipping foot and properly positioning the non-slipping foot under the pelvis. Trip training involved repeatedly practicing recovery from simulated trips on a modified treadmill. While standing on a modified treadmill, the treadmill belt was quickly accelerated posteriorly to elicit a forward loss of balance that mimicked a trip while walking. Participants attempted to step to avert a fall, and to establish a stable gait on the treadmill, after which the treadmill speed was slowed to zero to complete the trial.	Control Balance Training Four training sessions, conducted twice a week for two weeks in groups of 1-2 participants. Each session was 0.5-1 hours, with an active training time of 30 minutes for each participant. The control intervention involved general balance exercises adapted from the Otago Exercise program. Briefly, all four sessions involved balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support). Otago Balance Training: Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
Pre-intervention Evaluation (1 Week) Did not attend due to schedule conflict	2	1
Pre-intervention Evaluation (1 Week) testing error during evaluation	1	2
Post-intervention Evaluation (1 Week) Withdrawal by Subject	1	2
Post-intervention Evaluation (1 Week) testing error during evaluation	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Reactive Balance Training n=20 Participants Group of participants who were assigned to reactive balance training.	Control Balance Training n=14 Participants Group of participants who were assigned to control balance training.	Total n=34 Participants Total of all reporting groups
Age, Continuous	68.9 years STANDARD_DEVIATION 4.4 • n=20 Participants	70.0 years STANDARD_DEVIATION 4.0 • n=14 Participants	69.3 years STANDARD_DEVIATION 4.2 • n=34 Participants
Sex: Female, Male Female	11 Participants n=20 Participants	8 Participants n=14 Participants	19 Participants n=34 Participants
Sex: Female, Male Male	9 Participants n=20 Participants	6 Participants n=14 Participants	15 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Mass	77.8 kilograms STANDARD_DEVIATION 15.5 • n=20 Participants	80.0 kilograms STANDARD_DEVIATION 14.7 • n=14 Participants	78.7 kilograms STANDARD_DEVIATION 15.0 • n=34 Participants

PRIMARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

highest instantaneous speed of slipping foot during actual slip

Outcome measures

Measure	Baseline SLIP Group n=11 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Peak Slip Speed	2.8 meters/sec Standard Deviation .32	—

PRIMARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

highest instantaneous speed of slipping foot during actual slip

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=11 Participants Group of participants who were slipped after the reactive balance training intervention.
Peak Slip Speed	3.15 meters/sec Standard Deviation .33	2.58 meters/sec Standard Deviation .41

PRIMARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle

Outcome measures

Measure	Baseline SLIP Group n=17 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Trunk Angle at Touchdown After Tripping	37 degrees Standard Deviation 9.6	—

PRIMARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

anterior-posterior trunk angle relative to vertical at instant of touchdown of initial recovery step over tripping obstacle

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=8 Participants Group of participants who were slipped after the reactive balance training intervention.
Trunk Angle at Touchdown After Tripping	36.9 degrees Standard Deviation 2.2	41.1 degrees Standard Deviation 3.7

SECONDARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

distance moved by slipping foot during actual slip

Outcome measures

Measure	Baseline SLIP Group n=11 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Slip Distance	80.8 centimeters Standard Deviation 4.5	—

SECONDARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

distance moved by slipping foot during actual slip

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=11 Participants Group of participants who were slipped after the reactive balance training intervention.
Slip Distance	74.2 centimeters Standard Deviation 6.6	71.4 centimeters Standard Deviation 4.5

SECONDARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted

Outcome measures

Measure	Baseline SLIP Group n=10 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Fall Incidence After a Laboratory-induced Slip	8 Participants	—

SECONDARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

the outcome of each slip was categorized as either a: fall, recovery, or harness-assisted

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=11 Participants Group of participants who were slipped after the reactive balance training intervention.
Fall Incidence After a Laboratory-induced Slip	3 Participants	2 Participants

SECONDARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

anterior-posterior step distance of first step over tripping obstacle

Outcome measures

Measure	Baseline SLIP Group n=17 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Recovery Step Length After Tripping	54.3 percent body height Standard Deviation 14.1	—

SECONDARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

anterior-posterior step distance of first step over tripping obstacle

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=8 Participants Group of participants who were slipped after the reactive balance training intervention.
Recovery Step Length After Tripping	53.7 percent body height Standard Deviation 8.8	64.1 percent body height Standard Deviation 10.5

SECONDARY outcome

Timeframe: during week 1, before the intervention that spanned weeks 2 and 3

the outcome of each trip was categorized as a: fall, recovery, or harness-assisted

Outcome measures

Measure	Baseline SLIP Group n=17 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group Group of participants who were slipped after the reactive balance training intervention.
Fall Incidence After a Laboratory-induced Trip	6 Participants	—

SECONDARY outcome

Timeframe: during week 4, after the intervention that spanned weeks 2 and 3

the outcome of each trip was categorized as a: fall, recovery, or harness-assisted

Outcome measures

Measure	Baseline SLIP Group n=5 Participants Group of participants who were slipped prior to intervention.	Post-Reactive Balance Training SLIP Group n=8 Participants Group of participants who were slipped after the reactive balance training intervention.
Fall Incidence After a Laboratory-induced Trip	3 Participants	1 Participants

Adverse Events

Reactive Balance Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Control Balance Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Reactive Balance Training n=11 participants at risk Participants assigned to the reactive balance training.	Control Balance Training n=5 participants at risk Participants assigned to the control balance training.
Musculoskeletal and connective tissue disorders Baker's cyst	9.1% 1/11 • Number of events 1 • The period of time over which adverse event data were collected was 4 weeks. This included week 1 of pre-intervention evaluation, weeks 2-3 of intervention, and week 4 of post-intervention evaluation.	0.00% 0/5 • The period of time over which adverse event data were collected was 4 weeks. This included week 1 of pre-intervention evaluation, weeks 2-3 of intervention, and week 4 of post-intervention evaluation.
Musculoskeletal and connective tissue disorders Arthritis pain	0.00% 0/11 • The period of time over which adverse event data were collected was 4 weeks. This included week 1 of pre-intervention evaluation, weeks 2-3 of intervention, and week 4 of post-intervention evaluation.	20.0% 1/5 • Number of events 1 • The period of time over which adverse event data were collected was 4 weeks. This included week 1 of pre-intervention evaluation, weeks 2-3 of intervention, and week 4 of post-intervention evaluation.

Additional Information

Michael Madigan

Virginia Tech

Phone: (540) 231-3543

Email: mlm@vt.edu

Results disclosure agreements

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