Pilot Study on Comparisons Between the Effectiveness of Mobile Video-guided and Paper-based Home Exercise Programs of Patients With Stroke Randomized Controlled Trial

NCT ID: NCT03509363

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-23
• Study Completion Date: 2019-05-30

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.

Detailed Description

In Hong Kong, stroke patients would be referred to ambulatory services, such as geriatric day hospital, or domestic physiotherapy service to continue their stroke rehabilitation after discharge from hospital care. However, some patients could not attend ambulatory services due to vary difficulties, such as transportation and absence of carers. The low frequency of domestic physiotherapy service also reduced the effectiveness of rehabilitation of patients. Traditionally, for continuation of training at home, therapists would prescribe home exercises programs in paper-based format to stroke patients prior to discharge. However, evidence showed that written and pictorial home exercise prescription does not lead to better adherence to a home exercise programme compared to having no written and pictorial instructions for patients with stroke less than 4 months. It was suggested that the barriers to adherence of home exercise including low self-efficacy and delivery mode of training program. It is worthwhile for physiotherapists to investigate the mode of delivery to enhance exercise adherence and selfefficacy of post-discharge home exercise for patients with stroke. Recent survey concerning the development of smart technology revealed that 80% of global internet users owned a smart phone and 47% owned a tablet. Thus, the increasing accessibility of smart technology offers an opportunity to advance the mode of delivery of exercise program so as to benefit patients of stroke from increase the adherence and self-efficacy of home exercises. The evidences of using smart technology to enhance adherence of home exercise have reported inconsistent results. A study showed that home exercise programmes filmed on an electronic tablet, with an automated reminder, was not superior to standard paper-based home exercise programmes in terms of adherence, motor function, or satisfaction for patients recovering from stroke. In contrast, another study showed that people with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; although the clinical importance of this added adherence is unclear. 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. Eligible subjects will then be randomly assigned to either Intervention Group or Control Group in a 1:1 ratio.

Investigators who are responsible for data collection will be blinded to the group allocation. Pre-discharge training sessions last for 10- 15 minutes will be provided to patients, and their carers if any, of both groups in order to make them familiar with the selected home exercises and the technique of using mobile phone to scan QR for intervention group. 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. On the other hand, participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration. 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. Outcome measures including self-reported exercise adherence, self-efficacy for exercise, Modified Functional Ambulatory Category and Modified Barthel Index will be assessed at 1 day, 1 month and 3 month after discharged on phone follow-up basis by a blinded-assessor. We aim to recruit 28 participants in each group.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Stroke physiotherapy home exercise video

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stroke physiotherapy home exercise video

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

Intervention Type: BEHAVIORAL

Other Intervention Names

exercise video

Eligibility Criteria

Inclusion Criteria

• 1. 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).

4. Discharged home without any further training in ambulatory service such as Geriatric Day Hospital (GDH) and domestic physiotherapy services.

5. 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.

6. Participants or carers could read Chinese.

Exclusion Criteria

• 1. 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.

2. Participants and their carers have visual or cognitive impairments that would prevent use of smart devices.

3. Medical condition unstable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shatin Hospital

OTHER

Sponsor Role: collaborator

Tai Po Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Bryan Ping Ho CHUNG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ping Ho CHUNG, MSc

Role: PRINCIPAL_INVESTIGATOR

Hospital Authority, Hong Kong

Locations

Tai Po Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

TPH-PT-001

Identifier Type: -

Identifier Source: org_study_id