Walkbot Robotic Training for Improvement in Gait

NCT03554642 | Completed Phase 3 FDA Device

• 1 other identifier: BRC532
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will involve up to 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital. Participants will be randomized to receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). One group will receive 30 minutes of standard physical therapy focused on pre-gait or gait training activities, while the experimental group will receive 30 minutes of Walkbot with Augmented Reality. Both groups will receive the same time in therapy aimed at gait training.

Conditions

Ischemic Stroke; Gait, Hemiplegic

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment

  Lower extremity impairment measure

  Discharge evaluation (within 2 days after last session)

Secondary Outcomes (9)

• NIH Stroke Scale

  Baseline assessment and discharge evaluation within 2 days after last session

• Modified Ashworth Scale

  Baseline assessment and discharge evaluation within 2 days after last session

• Functional Ambulation Classification

  Baseline assessment and discharge evaluation within 2 days after last session

• 6 Minute Walk Test

  Baseline assessment and discharge evaluation within 2 days after last session

• 10 Meter Walk Test

  Baseline assessment and discharge evaluation within 2 days after last session

Study Arms (3)

Walkbot Training

EXPERIMENTAL

This group will receive usual inpatient care that includes at least one 60-minute session of physical therapy and an additional 30-minute session of Walkbot with Augmented Reality 5-days per week during the duration of their stay (14 days).

Device: Walkbot

Physical Therapy

ACTIVE COMPARATOR

This group will receive usual inpatient care including at least one 60-minute session of physical therapy per day, and an additional 30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days).

Behavioral: Physical Therapy

Usual Care Physical Therapy

NO INTERVENTION

Participants in this group will receive usual inpatient care including at least one 60-minute session of physical therapy per day.

Interventions

Walkbot DEVICE

Walkbot is a Robot Assisted Gait Training System. This system is designed to maximize muscle strength, range of joint motion, and gait function while participants engage in a virtual reality game.

Walkbot Training

Physical Therapy BEHAVIORAL

30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days).

Physical Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cortical/subcortical ischemic stroke
• st time clinical stroke presentation, or prior stroke with no residual deficits affecting ambulation
• Ability to follow 2 step commands
• Fugl Meyer Sensory Score \> 2
• Suitability for gait training as assessed clinically (ability to ambulate at least one step with a device/assistance)
• Height 132 cm- 200 cm; hip-knee joint length: 33 cm- 48 cm; knee joint-foot: 33 cm-48 cm

You may not qualify if:

• Cerebellar/brainstem stroke
• Body weight \>135 kg
• Uncontrolled high blood pressure (stage 2) higher than 160 (systolic)/ 100 (diastolic)
• Cardiopulmonary system impairments affecting the ambulation test.
• Integumentary impairment: skin breakdown and bedsore around the loading area of the suspension belt
• No previous robotic intervention for ambulation training
• Significant and persistent mental illness.
• A fixed contracture or deformity in lower extremity.
• Bone instability (non-consolidated fractures, unstable spinal column, severe osteoporosis necessitating treatment with bisphosphonates).
• Other neurodegenerative disorders (Amyotrophic lateral sclerosis, Parkinsonian disorder).
• Modified Ashworth scale \>3 in affected leg.
• Significant back or leg pain that creates an inability to tolerate movement.
• Decreased sensation that will impair patient's ability to percept whether the device is properly fitted
• Aphasia of a degree that would prevent the patient from communicating discomfort.
• Inability to tolerate the Walkbot device or ambulation therapy

Sponsors & Collaborators

• Burke Medical Research Institute: lead
• P&S Mechanics Co., Ltd.: collaborator

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Related Publications (1)

• Park C, Oh-Park M, Bialek A, Friel K, Edwards D, You JSH. Abnormal synergistic gait mitigation in acute stroke using an innovative ankle-knee-hip interlimb humanoid robot: a preliminary randomized controlled trial. Sci Rep. 2021 Nov 24;11(1):22823. doi: 10.1038/s41598-021-01959-z.

  PMID: 34819515 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Gait Disorders, Neurologic

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Kathleen Friel, PhD

  Burke Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential randomization into one of two groups within first week after admission.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 13, 2018
• Study Start: September 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)