Robot-aided Proprioceptive Rehabilitation Training

Not Applicable

Completed

• Conditions: Peripheral Sensory Neuropathy; Stroke
• Interventions: Behavioral: Proprioceptive training; Behavioral: Usual care

• Registration Number: NCT02565407
• Lead Sponsor: University of Minnesota

Brief Summary

This study investigates the effect of a robot-aided 2-day proprioceptive training of the wrist on the proprioceptive and motor function of the wrist/hand complex in patients with proprioceptive impairment. The wrist proprioceptive training consists of active movement training with augmented haptic and vibro-tactile feedback provided by a patented wrist robotic system (US Serial No. 62/136,065). This study protocol can be applied to a variety of clinical and non-clinical populations. The purpose of this study is to obtain preliminary data on the effectiveness of the proprioceptive training in subjects with cortical stroke or peripheral sensory neuropathy.

Detailed Description

This protocol seeks to improve proprioceptive-motor function. Proprioception refers to the perception of limb position or motion and the orientation of one's body in space. Numerous medical conditions with motor symptoms are also associated with proprioceptive loss, such as osteoarthritis, Parkinson's disease, peripheral sensory neuropathy, stroke, and developmental coordination disorder.

However, therapies to improve proprioceptive function in these populations are either non-existent or very limited in scope although it is established that proprioceptive impairments severely degrade motor function. The proposed protocol focuses on proprioception for fine motor function of the hand/wrist joint complex, because hand/wrist motor control is highly important for activities of daily living.

The specific aims are to determine if a 2-day wrist proprioceptive training:

1. improves limb position sense acuity,

2. improves the spatial precision of wrist/hand motor tasks,

3. increases the efficiency of performing such motor tasks,

4. is associated with neural changes in cortical processing as measured by short-latency somatosensory evoke potentials (SEP) and motor evoked potentials (MEP) using transcranial magnetic stimulation.

The study follows a crossover design with two arms and two groups. Time frame for the completion of the study is up to 7 days depending on the start day of the week (Monday through Friday). No testing will occur on the weekend.

Group 1 will have the following time frame: Day 1: pre-test (approx. 3 hrs.) and training intervention (approx. 30 min.). Day 2: training intervention (approx. 30 min.) and post-test 1 (approx. 3 hrs.). Days 3-6: Usual care (min. of 2 days required). Days 5-7: Post-test 2 (depending on the start day of the week, it is either Day 5,6, or 7).

Group 2 will have the following time frame: Day 1: pre-test 1 (approx. 3 hrs.). Days 2-4: Usual care (min. of 2 days required). Days 4-6: pre-test 2 (approx. 3 hrs.) and training intervention (approx. 30 min.). Days 5-7: Training intervention and post-test 1 (depending on the start day of the week, it is either Day 5,6, or 7).

Study Timeline

• Study First Submitted: 2015-08-27
• Study First Submitted QC: 2015-09-30
• Study Start: 2015-10
• Study First Posted: 2015-10-01
• Primary Completion: 2019-09-01
• Study Completion: 2021-05-24
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. wrist passive range of motion (ROM) more than 22.5° in flexion/extension
2. sense the vibro-tactile cues on either forearms in order to effectively receive the movement-related feedback
3. resist minimal resistance in gravity-eliminated position (score at least 2+/5 with the physical examination of manual muscle testing (Hislop, Avers, & Brown, 2013)) ) in all wrist movement directions.

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Exclusion Criteria

1. Regular intake of benzodiazepines.
2. Cognitive impairment: score ≥ 23 on Mini-mental state examination (Folstein, Robins & Helzer, 1983)
3. Depressive symptoms: score ≤ 19 on Beck depression inventory (Beck, Steer, & Carbin,1988).

Inclusion Criteria for Stroke Subjects

1. at least 3 months after stroke
2. whose age are between 30 to 75 years old.

Exclusion Criteria for Subjects undergoing the TMS procedure (Rossi, Hallett, Rossini, & Pascual-Leone, 2009)

• Has implanted metal in the body.
• Diagnosed with multiple sclerosis, major psychiatric conditions, epilepsy, history of seizures in the past 2 years, sleep deprivation, pregnancy, uncontrolled migraine, major traumatic head injury, severe heart disease, increased intracranial pressure, high consumption of alcohol, any conditions that predispose one to seizures
• Is currently taking any pro-epileptic medication (e.g. epileptogenic drugs such as tricyclic antidepressants)
• When no electromyography response can be elicited within the range of the TMS stimulator
• Pregnant at the time of data collection .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proprioceptive training	Proprioceptive training	This arm will receive specialized robot-aided proprioceptive training of the wrist next to usual care.
Usual care	Usual care	This arm will receive what participants have been receiving from their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy at home, day rehabilitation, or outpatient visits.

Primary Outcome Measures

Name	Time	Method
Joint position sense acuity of the wrist (just-noticeable-difference threshold)	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Using the wrist robot, the just-noticeable-difference threshold (JND) of wrist position will measured by a 2-alternative forced choice psychophysical paradigm. Participant's wrist will be passively flexed to two positions (the standard stimulus and the comparison stimuli) in random order. The standard stimulus is always 15° wrist flexion from neutral wrist position and the comparison stimulus is always larger than the standard. Participants indicate verbally which stimulus was perceived as having a larger amplitude. Unit is degrees.

Secondary Outcome Measures

Name	Time	Method
Root-mean-square tracing error as a measure of movement accuracy	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Using the wrist robot, participants perform wrist movements to move a cursor on a screen. Task is to trace various template wave forms (saw tooth, sine wave, irregular, figure-of eight) displayed on the screen. The same procedure will be performed with a pen stylus on a digital tablet. The cursor position will be recorded continuously through the tracking task. Root-mean-square tracing error is calculated based on the difference between the cursor path and the template waveform. Unit is in mm.
Movement time	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Movement time is the time it takes to complete either the tracing or pointing task. Unit is in seconds.
Jerk cost as a measure of movement smoothness	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	The jerk cost is defined as the integral of the first derivative of acceleration.
Fugl-Meyer Assessment score	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Fugl-Meyer Assessment is a clinical instrument used to evaluate and measure recovery in post-stroke patients. Only the motor section for the upper extremity of the assessment is used (Fugl-Meyer et al., 1974). Range of possible scores is 0 \[no recovery\] - 66 \[full recovery\].
Nottingham Sensory Assessment score	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Erasmus-modified Nottingham Sensory Assessment is a clinical instrument to evaluate somatosensory function. For this study only the proprioception section of upper limb is used (Stolk-Hornsveld, Crow, Hendriks, Van Der Baan, \& Harmeling-Van Der Wel, 2006). Range of possible scores is 0 \[absent\] - 2 \[intact\].
Peak-to-peak amplitude of motor-evoked potential (MEP)	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	Single-pulse transcranial magnetic stimulation (TMS) is used to assess corticospinal excitability by eliciting MEP of the wrist extensor muscles using a method described by Samargia et al. (2014). Unit is millivolts.
Canadian Occupational Performance Measure (COPM)	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	COPM is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living (Law et al., 1994). One to five activities will be chosen by the participant. Range of possible scores is 1 \[poor performance and low satisfaction\] - 10 \[very good performance and high satisfaction\] per activity.
Mean somatosensory-evoked potential (SEP) latencies for N20 and N30	For Group1: Change from pre-test at Day 1 (prior to training) to post-test 1 at Day 2. For Group 2: Change from pre-test 2 at Days 4-6 to post-test 1 at Days 5-7.	SEPs after median nerve stimulation are recorded. The latencies for N20 and N30 will be identified. Unit is in milliseconds.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States