NCT03509363

Brief Summary

This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. The objective of the study is to compare the effectiveness of video-guided exercise program and standard paperbased home exercise program on adherence of exercise, self-efficacy and improving functional outcomes in patients with stroke within 3-month follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable stroke

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 26, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 23, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

April 17, 2018

Last Update Submit

September 23, 2019

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Chinese version of the Modified Barthel Index

    MBI was used to assess patients' basic activities of daily living (ADL) in this study. MBI measures the participant's performance on ten functional items including self-care, continence, and locomotion.

    3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants allocated to the intervention group will be prescribed a set of exercise video with QR code provided in home exercise pamphlets and they have to perform the prescribed exercises under the guidance of video.The content of home exercise program in both groups is the same and is based on the recommendations from the National Stroke Foundation Clinical Guidelines, including mobilization exercise, strengthening exercise and balance training which is tailor-made for different mobility level of stroke patients. Suitability of participating home exercise program will be assessed by physiotherapists based on environmental risk, fall risk and competence of patients or carers in performing exercise with patients. The number of exercises prescribed, frequency and intensity of exercise varies from participants and will be determinated by physiotherapists

Behavioral: Stroke physiotherapy home exercise video

Control

NO INTERVENTION

Participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration.

Interventions

Stroke physiotherapy home exercise videoBEHAVIORAL

a set of exercise video with QR code provided in home exercise pamphlets

Also known as: exercise video
Intervention

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Stroke as principle diagnosis. 2. Could follow gesture and instructions of exercise training. 3. Could sit independently without back support for 2 minutes (MFAC Category II Sitter).
  • \. Discharged home without any further training in ambulatory service such as Geriatric Day Hospital (GDH) and domestic physiotherapy services.
  • \. Participants or their carers have smart devices such as smart phones or tablets that are able to scan QR code and connect to the Internet.
  • \. Participants or carers could read Chinese.

You may not qualify if:

  • \. Participants who could walk independently with or without walking aids (MFAC Category 6, 7) before discharge from Tai Po Hospital and Shatin Hospital medical unit.
  • \. Participants and their carers have visual or cognitive impairments that would prevent use of smart devices.
  • \. Medical condition unstable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tai Po Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Stroke

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ping Ho CHUNG, MSc

    Hospital Authority, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All research study personnel, including those who collect data and assess outcomes will be blinded to the group assignment. The envelopes and the randomization list will not be revealed to any of the study personnel until completion of recruitment and data collection.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, controlled
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 26, 2018

Study Start

July 23, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Locations

HK(1)