UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056247 |
|---|---|
| Receipt number | R000064126 |
| Scientific Title | Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2024/11/23 00:58:51 |
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Basic information
Public title
Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients
Acronym
Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients
Scientific Title
Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients
Scientific Title:Acronym
Integrating behavioral medicine with physiotherapy to improve treatment adherence and performance: a mixed-method randomized controlled trial for physical rehabilitation of stroke patients
Region
| Asia(except Japan) |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility and acceptability of an integrated home-based functional electrical stimulation (FES) and a behavioral implementation intention intervention (III) for improving physical function among stroke patients with physical function limitations in Hong Kong; To evaluate the efficacy of the combined intervention and compare it with the efficacy of a home-based FES intervention alone and the efficacy of usual care (the control treatment) in terms of improving physical function of stroke patients (e.g., walking speed and mobility index)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcomes will be the feasibility and acceptability of intervention, such as eligibility rates, recruitment, and retention. Acceptability will be measured by drop-out rates and qualitative feedback obtained via interviews with intervention participants and interventionists at the conclusion of the trial.
Key secondary outcomes
Walking speed, balance, Stroke Impact Scale, Self-efficacy for Managing Chronic Disease Scale, and quality of life. Outcomes will be assessed at baseline, post-intervention Month 0, 2, and 4.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Intervention group 1: Home-based functional electrical stimulation (FES) intervention will require participants to walk daily for at least 1 hour using a commercial FES device for 2 consecutive months. The study device is a battery-operated single-channel electrical stimulator approved by the US Food and Drug Administration for treating foot drop. The participants will first receive training in the set-up, fitting, and safe use of the device. Once the participants can walk safely and consistently with supervision, they will be given an FES device for use in ongoing gait practice at home and in the community.
Interventions/Control_2
Intervention group 2: Combined intervention (Home-based FES intervention + III) will receive behavioral implementation intention intervention (III) in addition to the FES intervention. A volitional help sheet will be used to help participants make specific action and coping plans, with two telephone follow-up calls.
Interventions/Control_3
Control group
The participants in the control group will receive the usual treatment and care that follow the government guidelines, including the instruction on upper limb training.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The eligibility criteria for participation include: (1) aged 18 years or older, (2) having a post-stroke period of 6 to 60 months, (3) exhibiting impaired ankle voluntary movement with muscle strength of dorsiflexion less than grade 4, (4) being able to walk for 6 minutes with or without walking aids, (5) being able to communicate effectively and provide informed consent.
Key exclusion criteria
The exclusion criteria will be (1) currently participating in other rehabilitative projects; (2) a serious medical condition preventing study procedures (consent and assessment); (3) severe pain in the lower limbs and back; (4) contraindications to doing physical exercise; (5) contraindications to FES use (e.g., skin problems or recently open wound in the affected leg, or any electric or metallic implants).
Target sample size
51
Research contact person
Name of lead principal investigator
| 1st name | Rui |
| Middle name | |
| Last name | She |
Organization
The Hong Kong Polytechnic University
Division name
Department of Rehabilitation Sciences
Zip code
999077
Address
Yuk Choi Road 11, Hung Hom, Kowloon ,Hong Kong China
TEL
85227665693
sherry-rui.she@polyu.edu.hk
Public contact
Name of contact person
| 1st name | Rui |
| Middle name | |
| Last name | She |
Organization
The Hong Kong Polytechnic University
Division name
Department of Rehabilitation Sciences
Zip code
999077
Address
Yuk Choi Road 11, Hung Hom, Kowloon ,Hong Kong China
TEL
85227665693
Homepage URL
sherry-rui.she@polyu.edu.hk
Sponsor or person
Institute
The Hong Kong Polytechnic University
Institute
Department
Personal name
Funding Source
Organization
Health and Medical Research Fund, Health Bureau, Hong Kong
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Hong Kong Polytechnic University
Address
Yuk Choi Road 11, Hung Hom, Kowloon ,Hong Kong China
Tel
85227665693
85227665693
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064126
