Health TrialsbyHealthPanel

Facilitating Neuroplastic Changes of Acute Stroke Survivors

ConditionStroke
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Maryland, Baltimore

About this trial

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)

Hemiplegia or hemiparesis

0≤Manual Muscle Testing (MMT)<=2

Age 30-85

Disqualifiers

Medically not stable

Associated acute medical illness that interferes with ability to training and exercise

No impairment or very mild ankle impairment of ankle

Severe cardiovascular problems that interfere with ability to perform moderate movement exercises

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motor relearning training

    Device

    Ankle motor control relearning training under real-time feedback

  • Passive stretching

    Device

    Passive stretching under intelligent robotic control

  • Gamed-based active movement training

    Device

    Active movement training through movement games with robotic assistance

  • Passive movement

    Device

    Passive movement in the joint middle range of motion

  • Active movement training

    Device

    Active movement training without robotic assistance

  • Ankle torque and motion measurement

    Device

    Ankle torque and motion measurement with no real-time feedback

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Study group - Wearable ankle robot rehabExperimental treatment 3 interventions
Group B: Control group - Limited wearable ankle robot rehabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Fugl-Meyer Lower Extremity (FMLE)

The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.

Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends]

Secondary outcomes

1

Active range of motion (AROM)

AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.

Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends
2

Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.

Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.

Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends
3

Strength of the ankle flexor-extensor muscle will be measured in Newtons

Strength of the ankle flexor-extensor muscle will be measured in Newtons

Time frame
At the beginning and end of 3-week training, and 1 month after the treatment ends
4

Modified Ashworth Scale (MAS)

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 ROM (range of movement); 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
At the beginning and end of 3-week training, and 1 month after the treatment ends

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Maryland, Baltimore

Lead sponsor

The University of Texas Health Science Center, Houston

Collaborator

Source ClinicalTrials.gov
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