NCT05212181

Brief Summary

Hemiparetic weakness is common after stroke and only a small group of patients achieve useful upper limb function despite best rehabilitation efforts. This is due to the lack of intensive upper limb therapies to drive neuroplasticity either in clinic or at home. In this study, we plan to pilot home-based, robot-aided-therapy using H-man to deliver intensive arm rehabilitation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
14 days until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

9 months

First QC Date

January 18, 2022

Last Update Submit

September 20, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Fugl Meyer Motor Assessment

    Change in Fugl Meyer Motor Assessment score in the affected arm

    Assessed at week 5 from baseline (week 0)

Secondary Outcomes (7)

  • Aggregated number

    Assessed at weeks 0, 5, 12 and 24

  • Streamlined Wolf-motor function test (SWMFT)

    Assessed at weeks 0, 5, 12 and 24

  • Action Research Arm Test (ARAT)

    Assessed at weeks 0, 5, 12 and 24

  • Grip strength (KgF) measured by Digital Dynamometer (mean of 3 readings will be recorded)

    Assessed at weeks 0, 5, 12 and 24

  • Self-efficacy outcomes by UPSET (upper limb self-efficacy test)

    Assessed at weeks 0, 5, 12 and 24

  • +2 more secondary outcomes

Interventions

H-ManDEVICE

H-Man device will be deployed to patients for onboarding and home-based training.

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in outpatient clinics

You may qualify if:

  • \) Clinical stroke (ischaemic or haemorrhagic) confirmed by admitting doctors and CT, CT angiography or MRI brain imaging (2) Age 21 to 90 years, both males and females (3) At least \> 28 days (4) Upper limb motor impairment of Fugl-Myer Motor Assessment (FMA) scale 10 to 60 (5) Has a stable home abode and a carer/ NOK to supervise home based exercise. (6) Ability to sit supported continuously for 60 minutes (7) Montreal Cognitive Assessment (MOCA) score \> 21/30 (8) Able to understand purpose of research and give consent

You may not qualify if:

  • Non-stroke related causes of arm motor impairment
  • Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, ischaemic heart disease, congestive heart failure, bronchial asthma, severe /untreated depression, agitation, end stage renal/liver/heart/lung failure, unresolved cancers.
  • Anticipated life expectancy of \< 6 months
  • Inability to tolerate sitting continuously for 60 minutes (5 Local factors potentially worsened by intensive robot-aided arm therapy and computer-based training: active seizures within 3 months, spasticity of Modified Ashworth Scale grades \>2 skin wounds, shoulder, arm pain VAS \>5/10, active upper limb fractures, arthritis, fixed upper limb flexion contractures.
  • (6) Hemi anaesthesia of affected limb (7) Severe visual impairment or visual neglect affecting ability to use H-Man robot (8) History of dementia, severe depression or behavioural problems (9) Pregnant or lactating females will not be allowed to participate (10) Absence of reliable carer to provide supervision during home training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (1)

  • Aguirre-Ollinger G, Chua KSG, Ong PL, Kuah CWK, Plunkett TK, Ng CY, Khin LW, Goh KH, Chong WB, Low JAM, Mushtaq M, Samkharadze T, Kager S, Cheng HJ, Hussain A. Telerehabilitation using a 2-D planar arm rehabilitation robot for hemiparetic stroke: a feasibility study of clinic-to-home exergaming therapy. J Neuroeng Rehabil. 2024 Nov 26;21(1):207. doi: 10.1186/s12984-024-01496-6.

    PMID: 39593101DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Dr Poo Lee Ong, MBBS

    Tan Tock Seng Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2022

First Posted

January 27, 2022

Study Start

February 10, 2022

Primary Completion

November 10, 2022

Study Completion

December 31, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)