Effects of Exoskeleton-Assisted Gait Training on Functional Rehabilitation Outcomes in Patients With Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Oklahoma
About this trial
The goal of this study is to determine the efficacy of electromechanical exoskeleton-assisted gait training on rehabilitation functional outcomes in patients with stroke undergoing therapy in an in-patient rehabilitation facility.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients with acute hemorrhagic or ischemic stroke documented clinically and by neuroimaging.
Medically stable from a cardio-respiratory stand point so that they can participate in daily therapies.
Depressed patients will be included in the study
Patients able to stand alone
Disqualifiers
Aphasic patients unable to communicate
Confused patients
Patients medically unstable
Patients unable to stand alone
Trial design
Design model
Parallel
Treatments tested in this trial
Indego Exoskeleton
DevicePowered generated orthosis
Standard Rehabilitation
Other interventionStandard Rehabilitation
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Exo-groupExperimental treatment 2 interventions
Group B: Control-GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Functional Independence Measure (FIM™)
It measure the degree of disability as well as the progress patients make throughout their medical rehabilitation programs. FIM Scale score varies from minimum of 18 to maximum of 126. Higher score better the outcome.
Time frame
Baseline (Day 1) and at 4-weeks to measure change2
The two minute walk test (2-MWT)
It assess the walking distance over two minutes while moving at a comfortable speed. using any ambulation aids (such as cane, walkers, and rollators) used in everyday life. Normal walking speed is 360 ft.
Time frame
Baseline (Day 1) and at 4-weeks to measure changeSecondary outcomes
1
Modified Ashworth Scale (MAS)
Clinical measure of degree of spasticity. Score varies from 0=normal tome to 4=part rigid in flexion and extension. Lower the score the better the outcome.
Time frame
Baseline (Day 1) and at 4-weeks to measure change2
Discharge disposition
Looks at effectiveness of rehabilitation as to how many patients are discharged home. Higher percentage 65% and above the better outcome.
Time frame
4-weeks3
The Beck Depression Inventory (BDI)
It is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. It ranges in value from 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows: 0-9 indicates person is not depressed, 10-18 indicates mild-moderate depression, 19-29 indicates moderate-severe depression and 30-63 indicates severe depression.
Time frame
Baseline (Day 1) and at 4-weeks to measure changeSponsors and contacts
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Source ClinicalTrials.gov