Effect of SynPhNe Physio-neuro Platform on Hand Motor Function Rehabilitation of Acute and Subacute Stroke Patients

Summary

Stroke is a major cause of adult long term disability and the fourth leading cause of death and affects 1·8/1000 persons in Singapore. Post-stroke functional recovery of upper limb is poor with 80% of stroke survivors having some upper limb disability during the acute to subacute phase after stroke. Early rehabilitation is paramount for enhancing the survival and independence of stroke patients and inadequate supervised therapy hours is closely associated with poor rehabilitation outcome. However, high intensity and high repetition therapies, which facilitates neuroplasticity, have historically had a poor uptake because it is manpower intensive and places a high demand on stroke patients, many of whom cannot cope. High fatigue and sustained levels of effort are also generally perceived as placing the patient at risk if done at home without trained supervision.

Robotic rehabilitation system can provide high-intensity, repetitive, task-specific, interactive treatment of the impaired upper limb and can serve as an objective and reliable means of monitoring patient progress.

Stroke subjects also have a wide spectrum of disability resulting in unconscious co-contractions and compensatory muscle use. Although these disability elements are widely acknowledged to be present, technological tools for identifying and quantifying these are missing. This technology gap affects the optimization of therapy and the patients' understanding of their condition.

This study aims:

1. To investigate the feasibility and efficacy of using the SynPhNe device outside of conventional therapy time, compared with conventional occupational therapy alone, on hand motor function in acute and subacute stroke patients;
2. To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision;
3. To investigate subject and staff perceptions in terms of usability and benefit of the device;
4. To study clinical outcomes, EEG, EMG and TMS changes over the course of the study;
5. To compare the cost-benefit of SynPhNe therapy on inpatients with standard care.

Hypotheses:

1. SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients;
2. SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased;
3. SynPhNe therapy is a cost-effective inpatient rehabilitation option.

Conditions

• Stroke

Interventions

DEVICE

SynPhNe physio-neuro platform

The SynPhNe device training protocol lasting approximately 60 mins: 1. Preparation for setup (\~5 mins) 2. Instruction video led warm up with active single and multi-joint movements - (\~20 mins): • Wrist extension and flexion• Fingers extension and flexion• Arm pronation and supination• Open grasp and close grasp • Open pinch and close pinch• Pronate and close grasp/ supinate and open grasp 3. Rest break - (\~5 mins) 4. Video led task practice as per the tasks below (any 4 tasks only) - (\~30 mins) • Grasp, lift and transfer water bottle using cylindrical grasp• Grasp lift and transfer pen using pinch grip• Flip pages of a book using lateral pinch grip• Use chopsticks to lift, transfer and place a small object• grasp doorknob and turn clockwise/anticlockwise, spoon scoop to pick up macaroni, open/ close a cylindrical jar, put object in pouch while holding it open and close it, fold/crease/tear a A4 size paper or fold handkerchief, reach a basket at different heights with an object.

Sponsors & Collaborators

• SynPhNe Pte Ltd.

  collaborator UNKNOWN

• National University Hospital, Singapore

  lead OTHER

Principal Investigators

• Effie Chew, MBBS · National University Hospital, Singapore

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-04

Primary Completion

2025-10-06

Completion

2025-10-06

Countries

• Singapore

Study Locations