Active Somatosensory Exercise for Chronic Stroke

NCT ID: NCT04490655

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2023-05-31

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.

Detailed Description

Long-term disability is common sequela among people with stroke. On top of motor impairment, many stroke survivors suffer from somatosensory impairment of their paretic arm, leading to their inability to perform activities of daily living using upper limb. In this respect, recent research on motor recovery following stroke has begun to place more emphasis on the inclusion of somatosensory retraining in stroke rehabilitation program. Although evidence is still scarce, training paradigms that simultaneously combine both somatosensory and motor aspects are considered useful for motor recovery in stroke survivors. Principally, studies focusing on such form of training paradigm sought to employ robotic technologies to assist in the retraining of both motor and somatosensory function in stroke survivors. Robotic technologies have gained popularity recently for assessing somatosensory function in clinical setting due to its objective quantification of patients' performance and high inter-rater reliability. Thus, with the purpose of improving both motor and somatosensory functions in chronic stroke survivors, this proposed study will provide an intensive robotic-based behavioral training intervention to chronic stroke survivors from the community. The intervention will require active participation of the patients through an exploratory strategy.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active somatosensory training group

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.

Group Type: EXPERIMENTAL

Active somatosensory training

Intervention Type: 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.

Motor-based training group

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.

Group Type: ACTIVE_COMPARATOR

Motor-based training

Intervention Type: 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.

Interventions

Active somatosensory training

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.

Intervention Type: BEHAVIORAL

Motor-based training

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanyang Technological University

OTHER

Sponsor Role: lead

Responsible Party

Ananda Sidarta

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ananda Sidarta, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Fellow

Locations

St Luke's Hospital

Bukit Batok New Town, , Singapore

AWWA Day Rehab Centre

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 26490869 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27852776 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20522675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34782024 (View on PubMed)

Other Identifiers

NTU-IRB-2019-10-022

Identifier Type: -

Identifier Source: org_study_id