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Completed

NCT Number: NCT06902948

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tai Po Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Sally Hiu Lam Wong

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2025
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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