At a glance
ClinicalIndex Comparison Record- ✓Chronic stroke (>6 months post-event)
- ✓Single stroke event only
- ✓Adequate cognition (Montreal Cognitive Assessment score >22)
- ✓Independently ambulatory in home environment
- ✕History of multiple strokes
- ✕History of other neurological disease
- ✕Uncontrolled medical issues
- ✕Lower limb muscle contractures that limit range of motion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Integration of Motor Learning Principles to Reduce Load Asymmetry Using a Novel Robotic Device in Individuals Chronically Post-Stroke
In Brief
A clinical study evaluating TPAD (Tethered Pelvic Assist Device) for Stroke. Completed, enrolled 12 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.