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

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ClinicalTrials.gov Identifier: NCT03203291
Recruitment Status : Active, not recruiting
First Posted : June 29, 2017
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Joel Stein, Columbia University

Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
Stroke Device: TPAD (Tethered Pelvic Assist Device) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Integration of Motor Learning Principles to Reduce Load Asymmetry Using a Novel Robotic Device in Individuals Chronically Post-Stroke
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : April 1, 2018

Arm Intervention/treatment
Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. Force Symmetry during gait [ Time Frame: change from baseline day 1 to post training day 5 ]
    Symmetry ratio of forces of affected limb/unaffected limb during gait

  2. Stance Time Symmetry [ Time Frame: change from baseline day 1 to post training day 5 ]
    Symmetry ratio of the percentage of time spent in stance phase of gait


Secondary Outcome Measures :
  1. Symmetry ratio of stride length [ Time Frame: from baseline day 1 to post training day 5 and at 1-week follow up ]
    Symmetry ratios computed (unaffected/affected )

  2. Symmetry ratio of gait velocity [ Time Frame: from baseline day 1 to post training day 5 and at 1-week follow up ]
    Symmetry ratios computed (affected/unaffected )

  3. Symmetry of percentage of time in swing phase of gait [ Time Frame: from baseline day 1 to post training day 5 and at 1-week follow up ]
    Symmetry ratios computed (unaffected/affected )and time in double support during overground gait.

  4. Symmetry of time spent in double support phase of gait [ Time Frame: from baseline day 1 to post training day 5 and at 1-week follow up ]
    Symmetry ratios computed (affected/unaffected )

  5. Balance [ Time Frame: from baseline day 1 to post training day 5 and at 1-week follow up. ]
    Berg Balance Scale Measures



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic (>6 months) post stroke
  • Single stroke event
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03203291


Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University

Responsible Party: Joel Stein, Professor and Chair, Dept. of Rehabilitation & Regenerative Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT03203291     History of Changes
Other Study ID Numbers: AAAR2407
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Joel Stein, Columbia University:
stroke
robotic training
gait

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases