Ischemic Stroke Clinical Trial
Official title:
Walkbot Robotic Training for Improvement in Gait in Sub-Acute Stroke
NCT number | NCT03554642 |
Other study ID # | BRC532 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | December 2019 |
Verified date | January 2020 |
Source | Burke Medical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Burke Medical Research Institute | White Plains | New York |
Lead Sponsor | Collaborator |
---|---|
Burke Medical Research Institute | P&S Mechanics Co., Ltd. |
United States,
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 |
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