NCT01905917

Brief Summary

The primary hypothesis tested in this randomized control trial is that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results greater functional recovery using the Jette Late Life Functional and Disability Instrument (LLFDI) (primary outcome) among stroke at three months survivors compared to usual care. The secondary hypotheses tested in this randomized control trial are that a tele-rehabilitation intervention involving video-conferencing with a therapist and use of wearable monitoring devices in the first three months after stroke results in:

  • Functional recovery using the LLFDI at 6 months,
  • Functional recovery using gait speed, 2-minute walk test and Shah modified Barthel Index at 3 and 6 months,
  • Greater contact time with a therapist at 3 \& 6 months,
  • Better balance at 3 \& 6 months,
  • Better self-report health-related quality of life at 3 \& 6 months,
  • Decreased health service utilization at 3 \& 6 months,
  • Reduced caregiver burden at three months survivors compared to usual care at 3 \& 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

2 active sites

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

July 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

3.3 years

First QC Date

July 18, 2013

Last Update Submit

September 12, 2017

Conditions

Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • Jette Late Life Functional and Disability Instrument (LLFDI)

    Disability component of the Jette Late Life Functional and Disability Instrument (LLFDI)

    3 months

Secondary Outcomes (1)

  • Jette Late Life Functional and Disability Instrument (LLFDI)

    6 months

Other Outcomes (7)

  • Gait speed

    3 & 6 months

  • Two-Minute Walk test

    3 & 6 months

  • Shah-modified Barthel Index

    3 & 6 months

  • +4 more other outcomes

Study Arms (2)

Control

NO INTERVENTION

Usual care

Tele-Rehabilitation

EXPERIMENTAL

A tele-rehabilitation intervention involving weekly video-conferencing with a therapist, training exercise videos and use of wearable sensors to capture patient participation in exercises.

Other: Tele-rehabilitation

Interventions

Tele-rehabilitationOTHER
Tele-Rehabilitation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 40 years;
  • Recent stroke (defined as stroke symptoms occurring within 4 weeks prior to admission into community hospitals);
  • Diagnosis of stroke made by clinician and/or supported by brain imaging;
  • Able to sit unsupported for 30 seconds;
  • Able to stand on the non-paretic leg for \>4 sec;
  • Able to walk at least 2m with maximum of 1 person assist;
  • Able to follow a 3-step command;
  • Living in the community before discharge and expected to be discharged home;
  • Has a caregiver.

You may not qualify if:

  • Has a pacemaker in-situ (because of possible interference of pacemakers by wireless electronic signals);
  • Unable to ambulate at least 150 feet prior to stroke, or intermittent claudication while walking less than 200 meters;
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of severe congestive heart failure, serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living);
  • History of serious chronic obstructive pulmonary disease or oxygen dependence;
  • Severe weight bearing pain;
  • Pre-existing neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) or severe dementia
  • History of major head trauma with severe residual deficits;
  • Lower extremity amputation;
  • Legal blindness or severe visual impairment;
  • Severe uncontrolled psychiatric illness such as psychosis, schizophrenia or medication refractory depression;
  • Life expectancy less than three months;
  • Severe arthritis or orthopedic problems that limit passive ranges of motion of lower extremity (knee flexion contracture of \> 10°, knee flexion ROM \< 90°, hip flexion contracture \> 25°, and ankle plantar flexion contracture \> 15°);
  • History of sustained alcoholism or drug abuse in the last six months;
  • Hypertension with systolic blood pressure greater than 200 mmHg and diastolic blood pressure greater than 110 mmHg at rest, that cannot be medically controlled into the resting range of 180/100 mmHg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Ang Mo Kio Thye Hua Kwan Hospital

Singapore, 569766, Singapore

Location

Related Publications (4)

  • Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK, Cen S, Hayden SK; LEAPS Investigative Team. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011 May 26;364(21):2026-36. doi: 10.1056/NEJMoa1010790.

    PMID: 21612471BACKGROUND

  • Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, Dobkin BH, Rose DK, Tilson JK; LEAPS Investigative Team. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurol. 2007 Nov 8;7:39. doi: 10.1186/1471-2377-7-39.

    PMID: 17996052BACKGROUND

  • Chumbler NR, Quigley P, Li X, Morey M, Rose D, Sanford J, Griffiths P, Hoenig H. Effects of telerehabilitation on physical function and disability for stroke patients: a randomized, controlled trial. Stroke. 2012 Aug;43(8):2168-74. doi: 10.1161/STROKEAHA.111.646943. Epub 2012 May 24.

    PMID: 22627983BACKGROUND

  • Koh GC, Yen SC, Tay A, Cheong A, Ng YS, De Silva DA, Png C, Caves K, Koh K, Kumar Y, Phan SW, Tai BC, Chen C, Chew E, Chao Z, Chua CE, Koh YS, Hoenig H. Singapore Tele-technology Aided Rehabilitation in Stroke (STARS) trial: protocol of a randomized clinical trial on tele-rehabilitation for stroke patients. BMC Neurol. 2015 Sep 5;15:161. doi: 10.1186/s12883-015-0420-3.

    PMID: 26341358DERIVED

Related Links

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Shih-Cheng Yes, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

  • Tay Arthur, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 23, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

SG(2)