Effectiveness of a Standardized Stroke Upper Limb Rehabilitation Program with Shortened Fugl-Meyer Assessment Stratification

NCT ID: NCT06902948

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2024-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the study was to investigate the effectiveness of a standardized stroke upper limb rehabilitation program with stratification using Shortened Fugl-Meyer Assessment (S-FM). The standardized program was compared with conventional training based on the hospital protocol.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Shortened Fugl-Meyer Assessment stroke rehabilitation upper limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standardized upper limb rehabilitation program

A new stroke upper limb rehabilitation program was designed. Participants were classified into 3 categories based on their level of upper limb impairment reflected by the baseline S-FM score (severe 0-4, moderate 5-8, mild 9-12). Upper limb training was provided according to the standardized treatment choices preset with expert opinions

Group Type EXPERIMENTAL

upper limb function training

Intervention Type OTHER

Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.

Conventional upper limb training

Treatments were prescribed based on the corporate stroke rehabilitation protocol of Hong Kong Hospital Authority. The protocol allowed variations in clinical practice and ultimate decision about a particular clinical treatment depended on each individual patient's condition and clinical judgment of individual therapists.

Group Type ACTIVE_COMPARATOR

upper limb function training

Intervention Type OTHER

Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

upper limb function training

Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* first stroke, able to attend gym training and give written consent

Exclusion Criteria

* unstable medical condition, any musculoskeletal conditions or other diseases restricted upper limb training, unfit mental state and unable to follow command
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sally Hiu Lam Wong

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sally Hiu Lam Wong

Advanced Practice Physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tai Po Hospital

Hong Kong, , Hong Kong

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong

References

Explore related publications, articles, or registry entries linked to this study.

McDonnell MN, Hillier SL, Esterman AJ. Standardizing the approach to evidence-based upper limb rehabilitation after stroke. Top Stroke Rehabil. 2013 Sep-Oct;20(5):432-40. doi: 10.1310/tsr2005-432.

Reference Type BACKGROUND
PMID: 24091285 (View on PubMed)

Garcia-Vega J, Gregory G, Lind CRP, Singer BJ. Development of a consensus approach to upper limb rehabilitation early post stroke amongst a cohort of Western Australian therapists. N Z J Physiother 2016;44(3):133-147

Reference Type BACKGROUND

Hirayama K, Takebayashi T, Takahashi K. Factors Influencing Decision-Making for Poststroke Paretic Upper Limb Treatment: A Survey of Japanese Physical and Occupational Therapists. Occup Ther Int. 2024 Oct 7;2024:1854449. doi: 10.1155/2024/1854449. eCollection 2024.

Reference Type BACKGROUND
PMID: 39403110 (View on PubMed)

Hsieh YW, Hsueh IP, Chou YT, Sheu CF, Hsieh CL, Kwakkel G. Development and validation of a short form of the Fugl-Meyer motor scale in patients with stroke. Stroke. 2007 Nov;38(11):3052-4. doi: 10.1161/STROKEAHA.107.490730. Epub 2007 Oct 4.

Reference Type BACKGROUND
PMID: 17916763 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CREC2022.343-T

Identifier Type: -

Identifier Source: org_study_id