Trial Outcomes & Findings for Development of Low Cost Devices to Increase Access to Treadmill Training (NCT NCT02560506)

Results Overview

Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

change from Baseline in treadmill speed at 8 weeks

Results posted on

2026-04-27

Participant Flow

Participant milestones

Participant milestones
Measure	Elastic Assisted Treadmill Walking Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic assisted treadmill walking: Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elastic Assisted Treadmill Walking n=19 Participants Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic assisted treadmill walking: Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Age, Categorical <=18 years	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=19 Participants
Age, Continuous	43 years STANDARD_DEVIATION 19 • n=19 Participants
Sex: Female, Male Female	6 Participants n=19 Participants
Sex: Female, Male Male	13 Participants n=19 Participants
Region of Enrollment United States	19 participants n=19 Participants
peak treadmill speed	.64 m/s STANDARD_DEVIATION .26 • n=19 Participants

PRIMARY outcome

Timeframe: change from Baseline in treadmill speed at 8 weeks

Population: same as above

Evaluation of the changes in treadmill speed (m/s) prior to and following use of the device

Outcome measures

Outcome measures
Measure	Elastic Assisted Treadmill Walking n=19 Participants Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic assisted treadmill walking: Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Change in Locomotor Performance During Treadmill Walking	0.8 m/s Standard Deviation .25

SECONDARY outcome

Timeframe: change from Baseline in treadmill speed at 8 weeks

consistency of hip-knee angles

Outcome measures

Outcome measures
Measure	Elastic Assisted Treadmill Walking n=19 Participants Participants will participate in treadmill training with a low cost pulley system device made of rubber bands (Theraband(R)), which will assist therapists in advancing limbs while gait training. Elastic assisted treadmill walking: Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
Gait Kinematics	0.84 no units Standard Deviation 0.16

OTHER_PRE_SPECIFIED outcome

Timeframe: outcomes will be assessed prior to and following up to 8 weeks of training

Gait speed (m/s) will be collected during overground walking

Outcome measures

Outcome data not reported

Adverse Events

Elastic Assisted Treadmill Walking

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

Dr. T. George Hornby

Indiana University

Phone: 3123508291

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place