NCT03203291

Reducing Asymmetry During Gait Using the TPAD (Tethered Pelvic Assist Device) for Stroke Patients

Completed NA Results posted Last updated 9 June 2020

What this trial tests

NA trial testing TPAD (Tethered Pelvic Assist Device) in Stroke in 12 participants. Completed in 1 May 2018.

Timeline

1 April 2017

Primary endpoint
1 May 2018

1 May 2018

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 April 2017
Primary completion	1 May 2018
Estimated completion	1 May 2018
Sites	1 location across United States

Drugs / interventions tested

• TPAD (Tethered Pelvic Assist Device)

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Columbia University

Who can join

Adults 18 to 75, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Force Symmetry Ratio During Gait Primary · Baseline through day 5

0-1 symmetry ratio comparing the impulse force of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.

Baseline

Group	Value	95% CI
TPAD Treatment	0.71	± 0.09

Day 5

Group	Value	95% CI
TPAD Treatment	0.83	± 0.23

Stance Time Symmetry Ratio Primary · Baseline through week 3

0-1 symmetry ratio of the percentage of time spent in the stance phase of a gait cycle. If the unaffected limb performs equivalent to the affected limb, the ratio will have a value of 1. The greater the disparity the closer the ratio is to 0. Stance time symmetry = Time in stance phase of gait cycle of Affected/Unaffected limb.

Baseline

Group	Value	95% CI
TPAD Treatment	0.81	± 0.04

Day 5

Group	Value	95% CI
TPAD Treatment	0.86	± 0.05

Week 3

Group	Value	95% CI
TPAD Treatment	0.83	± 0.05

Symmetry Ratio of Stride Length Secondary · Baseline through week 3

0-1 symmetry ratio comparing the stride length of the affected limb versus the unaffected limb during gait. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.

Baseline

Group	Value	95% CI
TPAD Treatment	1.04	± 0.05

Day 5

Group	Value	95% CI
TPAD Treatment	1.06	± 0.08

Week 3

Group	Value	95% CI
TPAD Treatment	1.03	± 0.05

Gait Velocity Secondary · Baseline through week 3

Walking velocity (speed) measured in meters walked per second (measured by Inertial Measurement Unit sensors worn in real time during walking).

Baseline

Group	Value	95% CI
TPAD Treatment	0.56	± 0.22

Day 5

Group	Value	95% CI
TPAD Treatment	0.57	± 0.20

Week 3

Group	Value	95% CI
TPAD Treatment	0.59	± 0.25

Symmetry of Percentage of Time in Swing Phase of Gait Secondary · Baseline through week 3

0-1 symmetry ratio compares the amount of time the unaffected leg is in swing phase of the gait cycle compared to the affected leg. The swing phase means the period of time during the gait cycle when one foot is not in contact with the ground. If the unaffected limb performs equivalent to the affected limb, the ratio has a value of 1. The greater the disparity between limbs, the closer the ratio is to 0.

Baseline

Group	Value	95% CI
TPAD Treatment	0.66	± 0.11

Day 5

Group	Value	95% CI
TPAD Treatment	0.73	± 0.11

Week 3

Group	Value	95% CI
TPAD Treatment	0.68	± 0.12

Time Spent in Double Support Phase of Gait Secondary · Baseline through week 3

The percentage of time in one gait cycle spent in double support phase of gait (2 feet in contact with the ground).

Baseline

Group	Value	95% CI
TPAD Treatment	31.62	± 9.74

Day 5

Group	Value	95% CI
TPAD Treatment	34.12	± 8.53

Week 3

Group	Value	95% CI
TPAD Treatment	31.76	± 10.38

Berg Balance Scale Secondary · Baseline through week 3

Berg Balance Scale measures balance ability of adults. The scale has 14 items, each is rated on a 5-point scale ranging from 0-4. A score of 0 indicates the lowest level of function and 4 indicating the highest level of function. Total scores range from 0-56, with higher scores indicating better balance.

Baseline

Group	Value	95% CI
TPAD Treatment	48.00	± 5.45

Day 5

Group	Value	95% CI
TPAD Treatment	49.09	± 4.72

Week 3

Group	Value	95% CI
TPAD Treatment	49.18	± 4.69

Sponsor's own description

OBJECTIVES: The purpose of this study is to evaluate the overall feasibility in terms of safety, treatment tolerance and adherence as well as preliminarily address how effective this treatment model using the TPAD and overground training would be to reduce load asymmetry on the treadmill and promote increased stance symmetry on the paretic limb during overground gait.PARTICIPANTS: A total of 12 individuals in the chronic (\>6 months) stages post stroke will be recruited from a voluntary stroke research database for participation. DESIGN: A non-randomized pilot study of feasibility will be used to establish the feasibility and preliminary efficacy of using the TPAD in combination with overground training to reduce load force asymmetry in this population. METHODS: Participants will undergo a series of three assessments within a one-week time frame prior to initiating intervention. Intervention using the TPAD and overground training will occur during week 2 over 5 consecutive visits (Mon-Fri). Participants will also complete short walks before and after the intervention with an instrumented system that records individual walking characteristics. Participants will return one-week after completing the intervention for a final test of walking and balance. Each study visit will be approximately 1-1.5 hours in duration, and total participation should be completed within three weeks. EXPECTED OUTCOMES: We anticipate this training paradigm will prove feasible and effective in reducing both load and stance asymmetry in a population of individuals with chronic stroke.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.