Robot Aided Rehabilitation - Multi-joint Evaluations
ConditionStroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorUniversity of Maryland, Baltimore
About this trial
Sensory and motor impairments following stroke can lead to substantial disability involving the arm and hand. The investigator hypothesized that excessive local and cross-coupled stiffness, diminished individuation and proprioceptive acuity will be present among multiple degree of freedom in the upper limb. The stiffness and spasticity will increase with time post-stroke. The objective of this study is to quantify the progression throughout the arm and hand during recovery from stroke. The investigator will measure the clinical assessment scores, and neuromechanical properties including range of motion, active and passive cross coupling, and spasticity by the IntelliArm robot.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
First focal unilateral lesion, ischemic or hemorrhagic
Had a stroke less than a month prior to enrollment
Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm
Rated between stages 1-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Hand
Disqualifiers
Apraxia
Other unrelated or musculoskeletal injuries
Unable to sit in a chair for 3 consecutive hours
Score of less than 22 on the Mini Mental Status Exam
Trial population
patients at a rehabilitation hospital, patients at an acute care hospital, patients from outpatient clinics, patients from day rehabilitation programs.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
56 Participants
are grouped into 2 trial groupsGroup A: Healthy
Group B: Stroke
Trial outcomes
Primary outcomes
1
Changes from baseline Graded Wolf Motor Function Test (WMFT) at six time points
The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.
Time frame
2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post strokeSecondary outcomes
1
Changes from baseline Fugl-Meyer Upper Extremity at six time points
The Fugl-Meyer Assessment is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
Time frame
2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post stroke2
Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at six time points
The Chedoke-McMaster Stroke Assessment (CMSA) is a screening and assessment tool utilized to measure physical impairment and activity of an individual following a stroke. The Chedoke Arm and Hand Activity Inventory (CAHAI) is used to assess functional ability of the paretic arm and hand. Each domain is scored on a 7-point scale.
Time frame
2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post stroke3
Changes from baseline Modified Ashworth Scale (MAS) at six time points
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Time frame
2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post stroke4
Changes from baseline Action Research Arm Test (ARAT) at six time points
ARAT assesses the ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
Time frame
2 week (baseline), 1 month, 2 month, 3 month, 4 month, 5 month and 6 month post strokeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
North Carolina State University
Collaborator
Source ClinicalTrials.gov