Walkbot Robotic Training for Improvement in Gait

Ischemic Stroke Clinical Trial

Official title:

Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554642
• Other study ID #: BRC532
• Status: Completed
• Phase: Phase 3
• Start date: September 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Burke Medical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This controlled clinical study will involve 30 ischemic stroke inpatients during their stay at Burke Rehabilitation Hospital (typical inpatient arrives 7 days post-stroke and is admitted for ~16 days).

Stroke inpatients will be sequentially randomized into one of two groups within the first week after admission. Both Groups will receive 30 additional minutes of therapy every day, for a total of 2 weeks (14 days). Group A will enroll 15 patients who 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). Group B will enroll 15 patients who 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). Both groups will receive the same time in therapy aimed at gait training. The extra therapy group will not exceed more than 15 minutes of pregait training before starting to walk the patient, and will spend at least 15 minutes doing active gait training per session. Patients in the treatment group will receive 30 minutes of total training on the Walkbot, excluding setup time. Primary and secondary outcomes will be collected, prior to the first therapy session. Follow up outcome measures will be collected within two days after the final interventional (study) therapy session. The amount of therapists needed for each session will be logged for every patient after Walkbot training or extra physical therapy. Borg rating of perceived exertion will be taken after each session from the patients, and NASA Task Load Index will be completed by the therapists (ie therapist load). Outcomes will be analyzed for significant differences.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Cortical/subcortical ischemic stroke

• 1st 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Ischemic Stroke

Intervention

Device:
• Walkbot
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.

Behavioral:
• Physical Therapy
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).

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Burke Medical Research Institute	P&S Mechanics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment	Lower extremity impairment measure	Discharge evaluation (within 2 days after last session)
Secondary	NIH Stroke Scale	Quantitative measure of stroke-related neurological deficit; The scale is comprised of 11 items with a maximal score of 42 and minimum of 0. Higher scores indicate severe stroke.	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Modified Ashworth Scale	Measure of spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Functional Ambulation Classification	Clinical measure of mobility	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	6 Minute Walk Test	Measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	10 Meter Walk Test	Examines gait speed	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Timed Up and Go	Assesses mobility in both static and dynamic balance	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Berg Balance Scale	Assesses balance during a series of 14 tasks; higher scores indicate greater independence.	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Burke Lateropulsion Scale	5 item scale measures lateropulsion or "Pusher Syndrome" by assessing reaction to change in postural position; 0 = no lateropulsion, 17= maximum score.	Baseline assessment and discharge evaluation within 2 days after last session
Secondary	Beck Depression Inventory	21 question, multiple choice, self-report inventory to assess depression; score of 0= minimal depression, 63= severe depression.	Baseline assessment and discharge evaluation within 2 days after last session