Interactive Intention-Driven Upper-Limb Training Robotic System
Trial: Interactive Intention-Driven Upper-Limb Training Robotic System
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study will investigate the recovery in hand and upper limb functions when the physical training is assisted by an exoskeleton robotic hand system.
Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
During the training, you will be asked to do the hand open and hand grasp by Electromyography-driven robotic control strategy.
There will be evaluations on the upper limb motor functions before and after the 20-session of training and follow up session by clinical assessments on functional recovery.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Hong Kong, Hong Kong
- The Hong Kong Polytechnic University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Subjects with a pure unilateral motor paresis after a stroke (ischemic or hemorrhagic). All subjects should have sufficient cognition to follow simple instructions as well as understand the content and purpose of the experiment, and also should be able to sit up for 1 hour.
Exclusion Criteria:
- Excessive spasticity of the affected arm
- Participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Hand Robotic Training
|
Training for 20 sessions for one hour, 3-5 times per week.
|
|
Experimentell: Hand and Arm Robotic Training
|
Training for 20 sessions for one hour, 3-5 times per week.
|
|
Aktiv komparator: Konventionell terapi
|
Training for 20 sessions for one hour, 3-5 times per week.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fugl-Meyer Assessment
Tidsram: Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
|
Evaluate the change from baseline assessment at the end of intervention and monitor the continuous change at three months and six months. Baseline assessment will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Fugl-Meyer Assessment at the end of intervention, at three months and at six months
|
|
Action Research Arm Test
Tidsram: Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Action Research Arm Test at the end of intervention, at three months and at six months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Wolf Motor Function Test
Tidsram: Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline Wolf Motor Function Test at the end of intervention, at three months and at six months
|
|
modified Ashworth Scale
Tidsram: Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
|
Evaluate the change from baseline test at the end of intervention and monitor the continuous change at three months and six months. Baseline test will be conducted at within one week prior to intervention. Participants will be followed for the duration of hospital stay, an expected average of 5 weeks for the 20-session intervention. The assessment at the end of intervention will be conducted within one week after the intervention. The other two assessments will be conducted at three months and six months after the last session of the intervention. |
Change from baseline modified Ashworth Scale at the end of intervention, at three months and at six months
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Raymond KY Tong, PhD, The Hong Kong Polytechnic University
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ITT/004/12GP
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