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

NCT ID: NCT03203291

Last Updated: 2020-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-05-01

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.

Detailed Description

There are a number of common impairments resulting from stroke that contribute to motor deficits which affect gait, or walking ability. These manifest as decreased walking speed, and further, as stroke affects only one side of the body, there are resulting asymmetries in time, spatial and force parameters during walking. Robotic-based therapies have been used to increase walking speed and reduce asymmetry in a population of individuals after stroke, however these therapies have demonstrated results similar to that of non-robotic, or conventional training. This is possibly due to the control strategies used in robotic training, which strategies limit participant involvement and reduce learning effect. The Tethered Pelvic Assist Device (TPAD) is a robotic device that uses motorized tethers attached to a belt at the user's pelvis to guide the pelvis along a pre-set movement trajectory. These tethers can be configured in an infinite array of possibilities, and most recently have been used to facilitate a body weight shift onto the paretic limb in a population of individuals after stroke. Other robotic devices constrain the limb through the entire movement trajectory and constrict the participants ability to participate in motor planning and movement execution. The TPAD promotes weight shifting, but allows an individual to freely move the limb and to navigate leg movement and foot placement independently, without constraints. Further, if coupled with overground training to promote transfer of improvements to walking over ground, this device maybe useful at improving symmetry in individuals after stroke.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tethered Pelvic Assist Device (TPAD) Treatment

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.

Group Type: EXPERIMENTAL

TPAD (Tethered Pelvic Assist Device)

Intervention Type: 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.

Interventions

TPAD (Tethered Pelvic Assist 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Sunil Agrawal

Professor of Mechanical Engineering and of Rehabilitation and Regenerative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sunil Agrawal, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32516301 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

AAAR2407

Identifier Type: -

Identifier Source: org_study_id