Active Somatosensory Exercise for Chronic Stroke

NCT04490655 | Completed DMC

• 1 other identifier: NTU-IRB-2019-10-022
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The current work aims to examine whether the proposed rehabilitation training or exercise will eventually yield improvements in both motor and somatosensory aspects at one goal. Here, the word 'somatosensory' refers to bodily sensations associated with proprioception or kinesthesia, not the sensation of touch, pain, and temperature. The study focuses on upper limb retraining for community-dwelling stroke survivors using a robotic device. At the end of training, both movement accuracy and somatosensory acuity in chronic stroke survivors are presumed to improve, and such paradigm is expected to provide reliable benefits as compared to conventional intervention alone.

Conditions

Stroke

Keywords

Somatosensory; Proprioception; Kinesthesia; Rehabilitation robotics; Positive reinforcement; Upper limb retraining

Outcome Measures

Primary Outcomes (2)

• Change in motor behavioral scores

  A robotic-based assessment to evaluate the movement accuracy of patients' paretic arm. This will be analyzed through their ability to propel the robotic handle to a target location as straight and as fast as possible. Key kinematic parameters such as endpoint deviation (cm) and movement smoothness will be computed where larger numbers indicate worse performance.

  Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).

• Change in somatosensory acuity

  A robotic-based assessment to measure performance in proprioception/kinesthesia of patients' paretic arm. This will be analysed through their ability to first passively sense where the arm is being moved to and later on to reproduce the movement made by the robot. Key kinematic parameters such as endpoint deviation (cm) will be computed where a larger number indicate worse performance.

  Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).

Secondary Outcomes (3)

• Change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).

• Change in streamlined Wolf Motor Function Test (WMFT)

  Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).

• Change in Erasmus-MC version of the Nottingham Sensory Assessment (EmNSA)

  Baseline, Post Day 1, Post Day 30 (where the last two sessions will be conducted 1 day and 30 days after the last intervention).

Study Arms (2)

Active somatosensory training group

EXPERIMENTAL

Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that focuses on the retraining of both motor and somatosensory functions, for a maximum of one hour per session.

Behavioral: Active somatosensory training

Motor-based training group

ACTIVE COMPARATOR

Chronic stroke patients will be randomized to receive 15 sessions of robotic-based training intervention that is purely motor based, for a maximum of one hour per session.

Behavioral: Motor-based training

Interventions

Active somatosensory training BEHAVIORAL

Patients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions.

Active somatosensory training group

Motor-based training BEHAVIORAL

Patients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions.

Motor-based training group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-time ischemic or haemorrhagic stroke survivors;
• Patients of at least 6-month post-stroke;
• Patients with severe to moderate sensory impairment as assessed by Erasmus Nottingham Sensory Assessment (≤ 6/8);
• Patients with arm motor impairment, shoulder abduction and elbow extension Medical Research Council (MRC) motor power grade 3-5;

You may not qualify if:

• Patients with bilateral impairment;
• Patients with high upper-limb spasticity (Ashworth scale \> 2);
• Patients with unilateral neglect as assessed by Star Cancellation Test (score \< 44);
• Patients with cognitive impairment as assessed by a 2-step instructions from the modified Mini Mental State Examination;
• Patients with a known history of mental disorders;
• Patients with the inability to perform upper arm activity due to excessive pain

Sponsors & Collaborators

• Nanyang Technological University: lead

Study Sites (2)

St Luke's Hospital

Bukit Batok New Town, Singapore

Location

AWWA Day Rehab Centre

Singapore, Singapore

Location

Related Publications (4)

• Bernardi NF, Darainy M, Ostry DJ. Somatosensory Contribution to the Initial Stages of Human Motor Learning. J Neurosci. 2015 Oct 21;35(42):14316-26. doi: 10.1523/JNEUROSCI.1344-15.2015.

  PMID: 26490869 BACKGROUND

• Sidarta A, Vahdat S, Bernardi NF, Ostry DJ. Somatic and Reinforcement-Based Plasticity in the Initial Stages of Human Motor Learning. J Neurosci. 2016 Nov 16;36(46):11682-11692. doi: 10.1523/JNEUROSCI.1767-16.2016.

  PMID: 27852776 BACKGROUND

• Goble DJ. Proprioceptive acuity assessment via joint position matching: from basic science to general practice. Phys Ther. 2010 Aug;90(8):1176-84. doi: 10.2522/ptj.20090399. Epub 2010 Jun 3.

  PMID: 20522675 BACKGROUND

• Sidarta A, Lim YC, Kuah CWK, Loh YJ, Ang WT. Robotic-based ACTive somatoSENSory (Act.Sens) retraining on upper limb functions with chronic stroke survivors: study protocol for a pilot randomised controlled trial. Pilot Feasibility Stud. 2021 Nov 15;7(1):207. doi: 10.1186/s40814-021-00948-3.

  PMID: 34782024 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

• Ananda Sidarta, PhD

  Research Fellow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: July 29, 2020
• Study Start: March 1, 2021
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Estimated time will be by March 2022, for 10 years.
• Access Criteria: Written request to the Principal Investigator

Locations

SG (2)