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

NCT05133232 | Completed DMC

• 1 other identifier: 2017/01009
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To evaluate the feasibility of the use of SynPhNe by acute and subacute stroke patients with minimized supervision;
3. 3.To investigate subject and staff perceptions in terms of usability and benefit of the device;
4. 4.To study clinical outcomes, EEG, EMG and TMS changes over the course of the study;
5. 5.To compare the cost-benefit of SynPhNe therapy on inpatients with standard care.
6. 6.SynPhNe therapy will have added benefit compared to conventional occupational therapy alone on hand motor function in acute and subacute stroke patients;
7. 7.SynPhNe can be used with minimal supervision by acute and subacute stroke patients so that the efficiency of rehabilitation is increased;
8. 8.SynPhNe therapy is a cost-effective inpatient rehabilitation option.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• Change of the upper extremity motor function using Fugl-Meyer scale

  Upper limb function, Minimum score 0, Maximum score 66, the higher the score the better the upper limb function.

  Change of the upper extremity motor function after intervention, Change of the upper extremity motor function 4 weeks after intervention

• Change of upper extremity performance (coordination, dexterity and functioning) using Action Research Arm Test

  Upper limb function, Minimum score 0, Maximum score 57, the higher the score the better the upper limb function.

  Change of upper extremity performance after intervention, Change of upper extremity performance 4 weeks after intervention

• Change of Grip strength % using Dynamometer

  Upper limb function

  Change of Grip strength % after intervention, Change of Grip strength % 4 weeks after intervention

• Change of cortical excitability using Transcranial Magnetic Stimulation (TMS)

  measures of cortical excitability for those without TMS contraindications

  Change of cortical excitability after intervention, Change of cortical excitability 4 weeks after intervention

Secondary Outcomes (2)

• Change of finger dexterity using 9-hole peg test

  Change of finger dexterity after intervention, Change of finger dexterity 4 weeks after intervention

• Change of spasticity using Modified Ashworth scale

  Change of spasticity after intervention, Change of spasticity 4 weeks after intervention

Study Arms (2)

SynPhNe physio-neuro platform

EXPERIMENTAL

Subjects will receive 15 to18 sessions of training at 60 minutes each on the use of the SynPhNe physio-neuro platform, for over the course of 4 weeks, outside of their conventional occupational therapy in accordance to a study protocol.

Device: SynPhNe physio-neuro platform

Conventional occupational therapy

NO INTERVENTION

Subjects will receive conventional occupational therapy (OT) only.

Interventions

SynPhNe physio-neuro platform DEVICE

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.

SynPhNe physio-neuro platform

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hemiparetic stroke (haemorrhagic or ischaemic) within 4 months of recruitment;
• FMA UE less than 55 (out of maximum of 66) but able to extend at least 2 fingers in the affected hand 10 degrees at any joint with pain-free passive range of motion at least 50% in all joints below the elbow;
• Age 21-90.

You may not qualify if:

• Cognitive or language impairment resulting in inability to follow instructions or inability to sustain attention for more than 10 minutes or inability to give consent;
• Poor sitting balance (inability to sustain unsupported sitting for \> 10min)
• Other orthopaedic or neurological diseases other than stroke affecting the function of the stroke-affected arm;
• severe pain in the stroke affected upper limb
• Terminal diseases with expected survival \<1 year
• Women who are pregnant or breastfeeding
• Patients who are in medically unstable conditions.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• SynPhNe Pte Ltd.: collaborator

Study Sites (1)

Alexandra hospital

Singapore, Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Effie Chew, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures will be conducted by a study staff who is blinded to the allocation of the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: November 24, 2021
• Study Start: July 4, 2019
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)