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

NCT03203291 | Completed Results FDA Device

• 1 other identifier: AAAR2407
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; robotic training; gait

Outcome Measures

Primary Outcomes (2)

• Force Symmetry Ratio During Gait

  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 through day 5

• Stance Time Symmetry Ratio

  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 through week 3

Secondary Outcomes (5)

• Symmetry Ratio of Stride Length

  Baseline through week 3

• Gait Velocity

  Baseline through week 3

• Symmetry of Percentage of Time in Swing Phase of Gait

  Baseline through week 3

• Time Spent in Double Support Phase of Gait

  Baseline through week 3

• Berg Balance Scale

  Baseline through week 3

Study Arms (1)

Tethered Pelvic Assist Device (TPAD) Treatment

EXPERIMENTAL

All participants will receive 5 consecutive days of training with the TPAD (tethered pelvic assist device) with testing completed before training, on completion of training and at a 1-week follow up.

Device: TPAD (Tethered Pelvic Assist Device)

Interventions

TPAD (Tethered Pelvic Assist Device) DEVICE

Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.

Tethered Pelvic Assist Device (TPAD) Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic (\>6 months) post stroke
• Single stroke event
• Montreal Cognitive Assessment (MoCA) score of \>22
• Independently ambulating in the home
• Use of a unilateral assistive device (e.g. cane)
• Marked asymmetry in stance phase (defined by a symmetry ratio \< 0.90)

You may not qualify if:

• History of multiple strokes
• History of other neurological disease
• Uncontrolled medical issues
• Muscle contractures of the lower limb limiting range of motion

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Bishop L, Omofuma I, Stein J, Agrawal S, Quinn L. Treadmill-Based Locomotor Training With Robotic Pelvic Assist and Visual Feedback: A Feasibility Study. J Neurol Phys Ther. 2020 Jul;44(3):205-213. doi: 10.1097/NPT.0000000000000317.

  PMID: 32516301 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sunil Agrawal, PhD
• Organization: Columbia University Irving Medical Center

sunil.agrawal@columbia.edu

(212) 854-2841

Study Officials

• Sunil Agrawal, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Mechanical Engineering and of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: June 29, 2017
• Study Start: April 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: June 9, 2020
• Results First Posted: October 28, 2019

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)