Robot-aided Proprioceptive Rehabilitation Training

NCT02565407 | Completed DMC

• 1 other identifier: 1505M72302
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Peripheral Sensory Neuropathy

Outcome Measures

Primary Outcomes (1)

• Joint position sense acuity of the wrist (just-noticeable-difference threshold)

  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.

  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.

Secondary Outcomes (8)

• 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.

• 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.

• 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.

• 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.

• 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.

Other Outcomes (1)

• Tactile sensitivity

  Measured on the first day of the intervention

Study Arms (2)

Proprioceptive training

EXPERIMENTAL

This arm will receive specialized robot-aided proprioceptive training of the wrist next to usual care.

Behavioral: Proprioceptive training

Usual care

ACTIVE COMPARATOR

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.

Behavioral: Usual care

Interventions

Proprioceptive training BEHAVIORAL

Training includes a virtual balance board and center-out task. Small vibratory motors placed on forearms provide vibro-tactile movement feedback (VTF). During familiarization participants learn to associate VTF with wrist movement and visual feedback. Vision is occluded after this phase. In the virtual balance board task participants use wrist motion to roll a ball to a target on the board. VTF indicates the desired movement direction and ball velocity. The center-out task involves wrist motion to control a cursor to reach a target. The wrist robot delivers an assistive force towards the target. VTF signals magnitude and direction of the cursor deviating away from the desired path.

Proprioceptive training

Usual care BEHAVIORAL

Usual care refers to care that participants receive through their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy received at in- or outpatient rehabilitation clinics or at home.

Usual care

Eligibility Criteria

• Age: 4 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• wrist passive range of motion (ROM) more than 22.5° in flexion/extension
• sense the vibro-tactile cues on either forearms in order to effectively receive the movement-related feedback
• 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.

You may not qualify if:

• Regular intake of benzodiazepines.
• Cognitive impairment: score ≥ 23 on Mini-mental state examination (Folstein, Robins \& Helzer, 1983)
• Depressive symptoms: score ≤ 19 on Beck depression inventory (Beck, Steer, \& Carbin,1988).
• at least 3 months after stroke
• whose age are between 30 to 75 years old.
• 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 .

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (11)

• Beck, A. T., Steer, R. A., & Carbin, M. G. (1988). Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical psychology review, 8(1), 77-100.

  BACKGROUND

• Bell-Krotoski JA, Fess EE, Figarola JH, Hiltz D. Threshold detection and Semmes-Weinstein monofilaments. J Hand Ther. 1995 Apr-Jun;8(2):155-62. doi: 10.1016/s0894-1130(12)80314-0.

  PMID: 7550627 BACKGROUND

• Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. doi: 10.1001/archpsyc.1983.01790060110016. No abstract available.

  PMID: 6860082 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

• Hislop, H., Avers, D., & Brown, M. (2013). Daniels and Worthingham's muscle testing: Techniques of manual examination and performance testing: Elsevier Health Sciences.

  BACKGROUND

• Law M, Polatajko H, Pollock N, McColl MA, Carswell A, Baptiste S. Pilot testing of the Canadian Occupational Performance Measure: clinical and measurement issues. Can J Occup Ther. 1994 Oct;61(4):191-7. doi: 10.1177/000841749406100403.

  PMID: 10137673 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

• Samargia S, Schmidt R, Kimberley TJ. Shortened cortical silent period in adductor spasmodic dysphonia: evidence for widespread cortical excitability. Neurosci Lett. 2014 Feb 7;560:12-5. doi: 10.1016/j.neulet.2013.12.007. Epub 2013 Dec 12.

  PMID: 24333913 BACKGROUND

• Stolk-Hornsveld F, Crow JL, Hendriks EP, van der Baan R, Harmeling-van der Wel BC. The Erasmus MC modifications to the (revised) Nottingham Sensory Assessment: a reliable somatosensory assessment measure for patients with intracranial disorders. Clin Rehabil. 2006 Feb;20(2):160-72. doi: 10.1191/0269215506cr932oa.

  PMID: 16541937 BACKGROUND

• Turgut N, Altun BU. Cortical disinhibition in diabetic patients with neuropathic pain. Acta Neurol Scand. 2009 Dec;120(6):383-8. doi: 10.1111/j.1600-0404.2009.01235.x.

  PMID: 19922582 BACKGROUND

• Yeh IL, Holst-Wolf J, Elangovan N, Cuppone AV, Lakshminarayan K, Cappello L, Masia L, Konczak J. Effects of a robot-aided somatosensory training on proprioception and motor function in stroke survivors. J Neuroeng Rehabil. 2021 May 10;18(1):77. doi: 10.1186/s12984-021-00871-x.

  PMID: 33971912 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juergen Konczak, Ph.D

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: May 24, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

US (1)