StrokeNCT06902948
Effectiveness of a Standardized Stroke Upper Limb Rehabilitation Program with Shortened Fugl-Meyer Assessment Stratification
A study testing upper limb function training in people with Stroke, run by Sally Hiu Lam Wong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- upper limb function training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Oct 2022to 26 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- first stroke, able to attend gym training and give written consent
Who cannot join
- unstable medical condition, any musculoskeletal conditions or other diseases restricted upper limb training, unfit mental state and unable to follow command
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- upper limb function training
- Keywords
- Shortened Fugl-Meyer Assessment, stroke rehabilitation, upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper limb function trainingOther
Intervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: upper limb function training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to the end of treatment up to 6 weeks
Secondary outcomes (1)
Modified Barthel Index (MBI)
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).
Measured: From enrollment to the end of treatment up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start11 Oct 2022
- Primary completion26 Jul 2024
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sally Hiu Lam Wong
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Sally Hiu Lam Wong, Tai Po Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902948
- Sponsor's protocol ID
- CREC2022.343-T
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 24091285Garcia-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
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.
PubMed 39403110Hsieh 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.
PubMed 17916763Lam 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.
PubMed 41477567
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Standardized Stroke Upper Limb Rehabilitation Program with Shortened Fugl-Meyer Assessment Stratification: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06902948
- Acronym / sponsor ID
- CREC2022.343-T
- Conditions
- Stroke
- Keywords
- Shortened Fugl-Meyer Assessment, stroke rehabilitation, upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Sally Hiu Lam WongOther government
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 26 Jul 2024 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 30 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized upper limb rehabilitation program | Experimental | Other: upper limb function trainingA 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 |
| Conventional upper limb training | Active comparator | Other: upper limb function trainingTreatments 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- first stroke, able to attend gym training and give written consent
Key exclusion criteria (1 listed)
- unstable medical condition, any musculoskeletal conditions or other diseases restricted upper limb training, unfit mental state and unable to follow command
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper limb function trainingIntervention selection included stretching and mobilization exercise, strengthening exercise, electrical stimulation, acupuncture, functional or task specific training and mirror therapy. | Other | Conventional upper limb training, Standardized upper limb rehabilitation program |
Primary outcome
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.
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.
1 secondary outcome
Modified Barthel Index (MBI)
Time frame: From enrollment to the end of treatment up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Background: PubMed 24091285McDonnell 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.
- BackgroundGarcia-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: PubMed 39403110Hirayama 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.
- Background: PubMed 17916763Hsieh 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.
- Derived from this study: PubMed 41477567Lam 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper limb function training in people with Stroke, run by Sally Hiu Lam Wong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shortened Fugl-Meyer Assessment (S-FM) (time frame: From enrollment to the end of treatment up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06902948, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.