The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
2015. november 3. frissítette: Taipei Medical University Hospital
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
55% to 75% of people after stroke have a paretic arm that causes motor impairment.
Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost.
MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere.
However, the benefits in certain aspects of outcomes are under debate.
Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed.
In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability.
The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT.
Adding MG to MT might augment the cortical reorganization.
In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
60
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
-
-
New Taipei City, Tajvan, 23561
- Shuang-Ho Hospital, Taipei Medical University
-
-
Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
20 év (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
Inclusion Criteria:
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
- No serious attention deficits
- No excessive spasticity in any of the joints of the affected UL exclusion criteria
Exclusion Criteria:
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Tényező hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Mirror therapy
mirror box training with or without sham mesh glove stimulation
|
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Más nevek:
|
|
Kísérleti: Mirror therapy + Mesh glove stimulation
Mirror therapy combined with mesh glove stimulation
|
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Más nevek:
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
Más nevek:
|
|
Aktív összehasonlító: Controlled intervention
conventional interventions
|
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
Más nevek:
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
Időkeret: Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
|
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment.
Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
|
Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
|
|
Wolf Motor Function Test (WMFT)
Időkeret: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
|
|
Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
|
|
Accelerometers
Időkeret: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
|
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory.
Acceleration is sampled at 10 Hz and summed over a user- specified epoch.
The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
|
Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
|
|
revised Nottingham Sensory Assessment (rNSA)
Időkeret: Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
|
The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
|
Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Kinematic analyses
Időkeret: Baseline, change from baseline in kinematic parameters at 4 weeks
|
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.
The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
|
Baseline, change from baseline in kinematic parameters at 4 weeks
|
|
Motor Activity Log (MAL)
Időkeret: Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
|
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale.
Higher scores indicate superior amount and quality of use in affected upper extremity.
|
Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
|
|
Semmes-Weinstein monofilaments
Időkeret: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
|
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
|
Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
|
|
Functional Independence Measure (FIM)
Időkeret: Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
|
The FIM consists of 18 items grouped into 6 subscales.
Each item is rated from 1 to 7 (max.
score 126) based on the required level of assistance to perform the tasks.
|
Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
|
|
Stroke Impact Scale version 3.0 (SIS 3.0)
Időkeret: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
|
The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains.
Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week.
Aggregate scores, ranges from 0 to 100, are generated for each domain.
|
Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
|
|
8-OHdG
Időkeret: Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
|
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions.
The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis.
A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
|
Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Nyomozók
- Kutatásvezető: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University
- Kutatásvezető: Tsan-hon Liou, PhD, Shuang-Ho Hospital, Taipei Medical University
- Kutatásvezető: Ching-yi Wu, ScD, Department of Occupational Therapy, College of Medicine, Chang Gung University
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2010. szeptember 1.
Elsődleges befejezés (Tényleges)
2014. május 1.
A tanulmány befejezése (Tényleges)
2014. május 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2012. július 27.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2012. augusztus 2.
Első közzététel (Becslés)
2012. augusztus 3.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. november 5.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. november 3.
Utolsó ellenőrzés
2012. november 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- CRC-09-10-08
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .