Active Somatosensory Exercise for Chronic Stroke (ActSens)

Nanyang Technological University

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Motor-based training; Behavioral: Active somatosensory training

Study type: Interventional

Funder types: Other

Identifiers

NCT04490655

NTU-IRB-2019-10-022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Active somatosensory training group

Experimental group

Description:

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.

Treatment:

Behavioral: Active somatosensory training

Motor-based training group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Motor-based training