A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient
5. august 2018 opdateret af: Lam So Ling, Stefanie, Shatin Hospital
This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
93
Fase
- Ikke anvendelig
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
45 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age between 45-85
- Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke
- Scoring > 6 of 10 of Abbreviated Mental Test
- Ability of the paretic hand to hold the game controller (minimal control)
- Able to give informed consent of the study
- Can understand instructions given by English or Cantonese
Exclusion Criteria:
- Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment
- Having cardiac pacemaker
- Receptive dysphasia
- Undergoing drug studies or other clinical trials
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bilateral movement-based computer training
All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care. Subjects in Intervention Group will be assigned an additional 30 minutes bilateral movement-based computer games(Able-X) training program of upper limb. |
|
|
Andet: Video-directed conventional training
All subjects underwent 16 sessions of assigned treatment (2 times per week; for 8 weeks; 3 hours standardized rehabilitation program per visit) There was 1.5 hours standardized conventional physiotherapy training a 1.5 hours multi-disciplinary program which consisted of standardized occupational therapy, speech therapy and nursing care.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 4 weeks
Tidsramme: Change from baseline to 4 weeks
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 4 weeks
|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to 8 weeks
Tidsramme: Change from baseline to 8 weeks
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 8 weeks
|
|
Fugl-Meyer Assessment-Upper Extremity Scores (FMA-UE scores) baseline to followup
Tidsramme: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index.
It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia.
It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The FMA-UE scores measure motor impairment of upper extremity.
The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist and hand.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Action Research Arm Test (ARAT) baseline to 4 weeks
Tidsramme: Change from baseline to 4 weeks
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 4 weeks
|
|
Action Research Arm Test (ARAT) baseline to 8 weeks
Tidsramme: Change from baseline to 8 weeks
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 8 weeks
|
|
Action Research Arm Test (ARAT) baseline to followup
Tidsramme: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia.
It assesses a client's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 4 weeks
Tidsramme: Change from baseline to 4 weeks
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 4 weeks
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to 8 weeks
Tidsramme: Change from baseline to 8 weeks
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 8 weeks
|
|
Short-Form Health Survey Hong Kong version (HK-SF-36) baseline to followup
Tidsramme: Change from baseline to 12 weeks (4 weeks after training ended)
|
The Short-Form Health Survey (SF-36) is a widely used, generic, patient-report measure created to assess health-related quality of life (HRQOL) in the general population.
SF-36 is the most commonly used generic instrument for measuring quality of life.
|
Change from baseline to 12 weeks (4 weeks after training ended)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. august 2015
Primær færdiggørelse (Faktiske)
1. februar 2017
Studieafslutning (Faktiske)
1. februar 2017
Datoer for studieregistrering
Først indsendt
6. oktober 2017
Først indsendt, der opfyldte QC-kriterier
5. august 2018
Først opslået (Faktiske)
7. august 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HMRF02133096
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