NCT04550039

Comparison of Two High-intensity Gait Training Interventions on Contraversive Pushing Behaviors in Individuals Poststroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of two high-intensity gait training interventions on contraversive pushing behaviors in individuals poststroke in the acute inpatient rehabilitation setting. We will also evaluate the effect of these interventions on functional mobility, strength, balance, and endurance. Furthermore, we intend to measure therapist burden when mobilizing individuals with contraversive pushing behaviors.

Detailed description

High-intensity gait training is strongly supported in individuals poststroke to facilitate neuroplastic changes in the brain in order to maximize the recovery of functional independence. Individuals with contraversive pushing behaviors (CPB) poststroke are difficult to mobilize as a result of tilted posture with significant balance impairments, a tendency to push toward their hemiparetic side, and resistance to external correction. CPB has been reported in 12-18% of individuals receiving stroke rehabilitation and often leads to longer lengths of stay, poorer functional outcomes, and institutionalized discharge locations compared to individuals poststroke without CPB. High quality evidence guiding physical therapy intervention, specifically gait training, in individuals with CPB is scarce. Traditional therapeutic interventions in individuals with CPB consists of progressing functional mobility while orienting to midline with various forms of visual and tactile feedback. To further guide best practice in this population, we plan to investigate the effect of two high-intensity gait training interventions on CPB in 10 individuals poststroke in the acute inpatient rehabilitation setting over the course of one year. Individuals from the inpatient stroke unit at the Shirley Ryan AbilityLab will be recruited and placed into one of two intervention groups. Intervention for group one will consist of body-weight-supported treadmill training + overground gait training. Intervention for group two will consist of gait training in the EksoNR exoskeleton + overground gait training. The commercially available EksoNR is approved by the FDA for use in individuals with stroke diagnoses. We will also evaluate the effect of these interventions on functional outcomes including mobility, strength, balance, walking speed, and walking endurance in addition to measuring therapist burden when mobilizing individuals with CPB. Both groups will receive their specified gait training intervention three sessions a week for at least three weeks until they discharge with the goal of maximizing the number of steps within a 60 minute session. Gait training interventions will be progressed to challenge individuals as appropriate in order to reach 70-85% of age-predicted maximum heart rate. A fourth session will be utilized to assess weekly outcome measures as part of the standard of care at the Shirley Ryan AbilityLab. There will be no restrictions set on therapy delivered outside of these intervention training sessions as individuals will be getting other therapies each day as the standard of care.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Body-weight-supported treadmill	Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
DEVICE	Ekso Bionics EksoNR exoskeleton	Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-09-16
• Last updated: 2024-03-01
• Results posted: 2024-03-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study