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

March 24, 2025 updated by: Sally Hiu Lam Wong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Tai Po Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: upper limb function training
Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.
Active Comparator: 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.
Other: upper limb function training
Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shortened Fugl-Meyer Assessment (S-FM)
Time Frame: From enrollment to the end of treatment up to 6 weeks
S-FM consisted of six items examining upper extremity movements (shoulder elevation, shoulder flexion 90° to 180°, elbow extension, elbow 90° pronation/supination, elbow 90° wrist flexion/extension and grasp, adduct thumb). Each item was scored with an ordinal scale of 0 (unable to perform), 1 (partially performed) and 2 (fully performed). The total score was 12.
From enrollment to the end of treatment up to 6 weeks
Functional Test for the Hemiplegic Upper Extremity (FTHUE)
Time Frame: From enrollment to the end of treatment up to 6 weeks
FTHUE consisted of 18 activities examining upper extremity function. Seven levels with 1-3 activities in each level in a hierarchy sequence of difficulty were adopted.
From enrollment to the end of treatment up to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Barthel Index (MBI)
Time Frame: From enrollment to the end of treatment up to 6 weeks
MBI consisted of 11 items examining ADL including self-care, continence and locomotion. A modified scoring system with 5 codes (unable to perform task, attempts task but unsafe, moderate help required, minimal help required and fully independent) was adopted for each item, giving a total score from 0 to 100 (0= fully dependent, 100= fully independent).
From enrollment to the end of treatment up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sally Hiu Lam Wong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Actual)

July 26, 2024

Study Completion (Actual)

July 26, 2024

Study Registration Dates

First Submitted

March 16, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 30, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC2022.343-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

IPD Sharing Time Frame

Beginning 3 months and ending 3 years

IPD Sharing Access Criteria

Researchers who are working on similar study topic with approved independent review can contact for IPD and supporting information sharing. A proposal that describes planned analyses and signed data sharing agreement have to be submitted to the corresponding author for review.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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