NCT03183635

Brief Summary

Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2017

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

September 14, 2016

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 12, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

1 year

First QC Date

September 14, 2016

Last Update Submit

December 10, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    A 14-item objective measure designed to assess static balance and fall risk in adult populations

    3-month follow-up

  • Timed Up and Go (TUG)

    It is used to assess mobility, balance, walking ability, and fall risk in older adults

    3-month follow-up

Secondary Outcomes (5)

  • Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke

    3-month follow-up

  • Activities-specific Balance Confidence (ABC) Scale

    3-month follow-up

  • Barthel Index of Activities of Daily Living

    3-month follow-up

  • Electromyography (EMG)

    3-month follow-up

  • "lean-and-release" postural system

    3-month follow-up

Study Arms (2)

Kinect based Rapid Movement Therapy

EXPERIMENTAL

Kinect based Rapid Movement Therapy (RMT) training requires participants to move their limbs very rapidly to reach-to-grasp or step towards a virtual target appear suddenly on a screen, which is designed to their range of motion as well as response speed.

Procedure: Balance training

Conventional balance training

PLACEBO COMPARATOR

Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises.

Procedure: Balance training

Interventions

Balance trainingPROCEDURE

Improvement of balance ability in stroke patients

Conventional balance trainingKinect based Rapid Movement Therapy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • have single stroke with onset \>1 year,
  • have unilateral paresis,
  • are 50 years of age or older,
  • able to stand without aid for at least 15min,
  • have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,
  • have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)\< 52/56,
  • have a minimum Snellen visual acuity of 20/40 with/without spectacles,
  • have a minimum Mini-Mental-Status-Examination score of 22/30, and
  • have to be able to follow the training procedures.

You may not qualify if:

  • enrolled in other rehabilitation program in the study duration,
  • have other neurological conditions in addition to stroke (e.g. Parkinson's disease),
  • have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure \>160mmHg/100mmHg), or
  • have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Biomedical Engineering, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.

    PMID: 34635141DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Raymond Kai-yu Tong, PhD

    Department of Biomedical Engineering, CUHK

    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
Professor

Study Record Dates

First Submitted

September 14, 2016

First Posted

June 12, 2017

Study Start

June 19, 2017

Primary Completion

June 22, 2018

Study Completion

October 30, 2018

Last Updated

December 11, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)