Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
26 juli 2016 uppdaterad av: China Medical University Hospital
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors.
It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society.
Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength.
Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients.
However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients.
Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse.
It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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Taichung, Taiwan, 408
- Rekrytering
- China Medical University Hospital
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Kontakt:
- Li-Wei Chou, MD, MSc
- Telefonnummer: 2381 +886-4-22052121
- E-post: chouliwe@gmail.com
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Huvudutredare:
- Li-Wei Chou, MD, PhD, MSc
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Underutredare:
- Nai-Hsin Meng, MD
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Underutredare:
- Andy Chien, PhD
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Between the age of 20-80 years;
- Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
- Paresis of a lower limb;
- Ability to walk for only a few meters either with or without aid.
Exclusion Criteria:
- Deemed by a physician to be medically unstable;
- Other prior musculoskeletal conditions that affected gait capacity;
- Co-existence of other neurological diseases;
- Cognitive impairments that would impact on the safe participation in the study (MMSE<23)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Static Standing Table Training
Patients in this group will receive standard hospital based rehabilitation as well as static standing table training
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As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
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Experimentell: Robotic Gait Training
Patients in this group will receive standard hospital based rehabilitation as well as robot-assisted gait rehabilitation training
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HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Berg Balance Scale
Tidsram: 15-20 minutes
|
The Berg Balance Scale (or BBS) is a widely used clinical test of a person's static and dynamic balance abilities and is generally considered to be the gold standard for clinical practice
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15-20 minutes
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pittsburgh Sleep Quality Index
Tidsram: 10-15 minutes
|
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval.
The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders
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10-15 minutes
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EuroQol five dimensions questionnaire (EQ-5D)
Tidsram: 10-15 minutes
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EuroQol five dimensions questionnaire (EQ-5D) is a standardized instrument for measuring generic health status.
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10-15 minutes
|
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Resting muscle tone
Tidsram: 10 minutes
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A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle tone (oscillation frequency [Hz]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
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10 minutes
|
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Resting muscle elasticity
Tidsram: 10 minutes
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A device developed by Myoton Technology (Myoton AS, Estonia) will be used to determine the resting muscle elasticity (Oscillation stiffness [N/m]) of the tibialis anterior muscle, gastrocnemius muscle, rectus femoris muscle and biceps femoris muscle.
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10 minutes
|
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Six minute walk test
Tidsram: 6 minutes
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The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in six minutes.
The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
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6 minutes
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Beck's depression Inventory
Tidsram: 7-10 minutes
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The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
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7-10 minutes
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2016
Primärt slutförande (Förväntat)
1 april 2017
Avslutad studie (Förväntat)
1 december 2017
Studieregistreringsdatum
Först inskickad
21 april 2016
Först inskickad som uppfyllde QC-kriterierna
26 april 2016
Första postat (Uppskatta)
28 april 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CMUH105-REC1-037
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will remain confidential and accessible to only the approved researchers
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