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

NCT04550039 | Completed Results DMC FDA Device

• 1 other identifier: STU00213155
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Gait; Exoskeleton; Robotics; Contraversive pushing behaviors

Outcome Measures

Primary Outcomes (2)

• Change in Scale for Contraversive Pushing

  The Scale for Contraversive Pushing is a three-item test used to measure lateropulsion also known as contraversive pushing behaviors. It is scored on a three point ordinal scale. It rates a participant's action/reaction of maintaining or changing a position in both sitting and standing. A score \>0 in each section indicates the presence of contraversive pushing behaviors. The maximum score is 6. The minimum score is 0, indicating an absence of pushing behaviors. The lower the score, the better.

  Baseline, 3 weeks

• Change in Burke Lateropulsion Scale

  The Burke Lateropulsion Scale is a five-item test used to measure lateropulsion, scored on a four to five point ordinal scale. It rates a participant's action/reaction of keeping or changing a position in sitting, standing, rolling in supine, transfers, and walking. A lower score is better. The minimum score is 0, indicating the absence of contraversive pushing behaviors. The maximum score is 17. Research indicates a score of ≥2 as a cutoff for the presence of contraversive pushing behaviors.

  Baseline, 3 weeks

Secondary Outcomes (13)

• Change in 10 Meter Walk Test

  Baseline, 3 weeks

• Change in 6 Minute Walk Test

  Baseline, 3 weeks

• Change in Berg Balance Scale

  Baseline, 3 weeks

• Change in Function in Sitting Test

  Baseline, 3 weeks

• Change in Functional Independence Measure

  Baseline, 3 weeks

Study Arms (2)

Body-weight-supported treadmill training

EXPERIMENTAL

Participants complete prescribed gait training program for at least three weeks or until they discharge.

Device: Body-weight-supported treadmill

EksoNR exoskeleton

EXPERIMENTAL

Participants complete prescribed gait training program for at least three weeks or until they discharge.

Device: Ekso Bionics EksoNR exoskeleton

Interventions

Body-weight-supported treadmill DEVICE

Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist

Body-weight-supported treadmill training

Ekso Bionics EksoNR exoskeleton DEVICE

Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist

EksoNR exoskeleton

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old
• Unilateral, supratentorial ischemic or hemorrhagic stroke within the past six months
• Medical clearance from primary medical team (signed Medical Clearance form)
• Contraversive pushing behaviors as determined by a score of \>0 on the Scale for Contraversive Pushing
• Adequate cognitive function as determined by the NIH scale: score ≤1 on question 1b and score =0 on question 1c
• Informed consent provided by participant or power of attorney
• English speaking

You may not qualify if:

• Severe aphasia limiting ability to express needs or discomfort verbally or nonverbally
• Severe behavioral neglect as determined by a score of ≥ 21 on Catherine Bergego Scale (CBS) via the Kessler Foundation-Neglect Assessment Process (KF-NAP)16
• History of prior stroke
• Concurrent neurologic condition (i.e PD, TBI, MS, etc.)
• History of peripheral nerve injury
• Joint contracture or significant spasticity in the lower limbs (Modified Ashworth Scale ≥3)
• Severe knee, hip, or ankle osteoarthritis
• Severe osteoporosis as indicated by physician medical clearance
• Open wounds on surfaces in contact with exoskeleton or harness
• Unstable spine or unhealed fractures
• Weight bearing precautions
• Unresolved deep vein thrombosis (DVT)
• Concurrent participation in other lower limb research studies that according to the PI is likely to affect study outcome or confound results
• Pregnancy
• Weight \>220 lbs (100 kg)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Katherine Enzler, Physical Therapist
• Organization: Shirley Ryan AbilityLab

kenzler@sralab.org

312-238-2941

Study Officials

• Arun Jayaraman, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 16, 2020
• Study Start: January 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)