Robot-aided Proprioceptive Rehabilitation Training

Stroke Clinical Trial

Official title:

Robot-aided Proprioceptive Rehabilitation Training With Additional Vibro-tactile Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565407
• Other study ID #: 1505M72302
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: May 24, 2021

Study information

• Verified date: September 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 24, 2021
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Peripheral Sensory Neuropathy
• Stroke

Intervention

Behavioral:
• Proprioceptive training
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.
• Usual care
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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (10)

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.

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. — View Citation

Folstein MF, Robins LN, Helzer JE. The Mini-Mental State Examination. Arch Gen Psychiatry. 1983 Jul;40(7):812. — View Citation

Fugl-Meyer AR, Jääskö 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. — View Citation

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

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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tactile sensitivity	Forearm tactile sensitivity assessment using the Semmes-Weinstein Monofilaments (Bell-Krotoski et al., 1995). Monfilaments measure both diminishing and returning cutaneous sensation. The monofilament bends at a force of 0.1N. Patient will report, yes, if the monofilament is perceived at that force level. Range of scores are + [perceived] and - [not perceived].	Measured on the first day of the intervention
Primary	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	Root-mean-square tracing error as a measure of movement accuracy	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.	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	Movement time	Movement time is the time it takes to complete either the tracing or pointing task. Unit is in seconds.	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	Jerk cost as a measure of movement smoothness	The jerk cost is defined as the integral of the first derivative of acceleration.	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	Fugl-Meyer Assessment score	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].	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	Nottingham Sensory Assessment score	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].	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	Canadian Occupational Performance Measure (COPM)	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.	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	Mean somatosensory-evoked potential (SEP) latencies for N20 and N30	SEPs after median nerve stimulation are recorded. The latencies for N20 and N30 will be identified. Unit is in milliseconds.	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	Peak-to-peak amplitude of motor-evoked potential (MEP)	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.	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.