Clinical trial NCT02565407: Robot-aided Proprioceptive Rehabilitation Training
Official title: Robot-aided Proprioceptive Rehabilitation Training With Additional Vibro-tactile Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Peripheral Sensory Neuropathy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: For all participants (both healthy and patient populations)

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.

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 .

Primary outcomes:
measure: Joint position sense acuity of the wrist (just-noticeable-difference threshold)
timeFrame: 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:
measure: Root-mean-square tracing error as a measure of movement accuracy
timeFrame: 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.
measure: Movement time
timeFrame: 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.
measure: Jerk cost as a measure of movement smoothness
timeFrame: 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.
measure: Fugl-Meyer Assessment score
timeFrame: 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.
measure: Nottingham Sensory Assessment score
timeFrame: 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.
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 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.
measure: Mean somatosensory-evoked potential (SEP) latencies for N20 and N30
timeFrame: 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.
measure: Peak-to-peak amplitude of motor-evoked potential (MEP)
timeFrame: 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:
measure: Tactile sensitivity
timeFrame: Measured on the first day of the intervention
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Juergen Konczak, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Hislop, H., Avers, D., & Brown, M. (2013). Daniels and Worthingham's muscle testing: Techniques of manual examination and performance testing: Elsevier Health Sciences.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.