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

NCT06902948 | Completed

• 1 other identifier: CREC2022.343-T
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

Shortened Fugl-Meyer Assessment; stroke rehabilitation; upper limb

Outcome Measures

Primary Outcomes (2)

• Shortened Fugl-Meyer Assessment (S-FM)

  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)

  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 Outcomes (1)

• Modified Barthel Index (MBI)

  From enrollment to the end of treatment up to 6 weeks

Study Arms (2)

Standardized upper limb rehabilitation program

EXPERIMENTAL

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

Conventional upper limb training

ACTIVE COMPARATOR

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

Interventions

upper limb function training 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; Standardized upper limb rehabilitation program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sally Hiu Lam Wong: lead

Study Sites (1)

Tai Po Hospital

Hong Kong, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 24091285 BACKGROUND

• 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

  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.

  PMID: 39403110 BACKGROUND

• 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.

  PMID: 17916763 BACKGROUND

• Lam Wong SH, Tung Chim TH, Ho Chung BP, On Lau TF. Effectiveness of a standardised stroke upper extremity rehabilitation program with shortened Fugl-Meyer assessment stratification: A randomised controlled trial. Hong Kong Physiother J. 2025 Dec;45(2):157-167. doi: 10.1142/S1013702525500131. Epub 2025 Nov 25.

  PMID: 41477567 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Advanced Practice Physiotherapist

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 30, 2025
• Study Start: October 11, 2022
• Primary Completion: July 26, 2024
• Study Completion: July 26, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years
• 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.

Locations

HK (1)