- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03112473
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
A Randomized, Controlled Clinical Trial of Upper Limb Training With Bilateral Cutaneous Electrical Stimulation to Improve Upper Limb Functions in Patients With Chronic Stroke
Přehled studie
Postavení
Podmínky
Detailní popis
The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT, Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.
The null hypothesis will be that Bi-TENS+TOT is not significantly different from Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and upper limb function and community integration in people with chronic stroke.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Hong Kong, Hongkong
- The Hong Kong Polytechnic University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Subjects will be recruited from local self-help groups through poster advertising.
- Subjects will be included if they are between 50 and 80 years of age
- Have been diagnosed with ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography within the previous 1 to 10 years
- have volitional control of the non-paretic arm and at least minimal antigravity movement in the shoulder of the paretic arm,
- have at least 5º in wrist extension in the antigravity position,
- score > 6 out of 10 in the Abbreviated Mental Test, and
- are able to follow instructions and give informed consent.
Exclusion Criteria:
• have any additional medical, cardiovascular or orthopedic condition
- use a cardiac pacemaker
- have receptive dysphasia
- have a significant upper limb peripheral neuropathy
- are involved in drug studies or other clinical trials, or
- have severe shoulder, elbow, wrist or finger contractures that would preclude a passive range of motions of the arm, and
- have a skin allergy that would prevent electrical stimulation.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Aktivní komparátor: Bilateral TENS (Bi-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral electrical stimulation
|
Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan).
The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
|
Komparátor placeba: Unilateral TENS (uni-TENS) group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with unilateral electrical stimulation on paretic side and sham electrical stimulation on the non-paretic side
|
Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan).
The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
A identical-looking TENS devices that electrical circuit has been disconnected.
|
Komparátor placeba: Placebo group
All subjects will undergo 20 sessions of their assigned intervention (60 minutes, thrice a week, for 8 weeks).
All subjects will receive 60 minutes task-oriented upper limb training (TOT) with bilateral sham electrical stimulation
|
Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment.
In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
A identical-looking TENS devices that electrical circuit has been disconnected.
|
Žádný zásah: Control group
No Active intervention
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
FMA-UE was used for evaluating the upper limb motor control from proximal to distal part of the limb, and voluntary movement from synergistic to isolated in people with stroke.
The FMA-UE has shoulder-arm, wrist, hand and coordination and speed subsections.
The score of shoulder-arm, wrist, hand and coordination and speed sub-scale are combined to compute the total score.
The maximum total score is 66, with 33 items and ordinal scoring from 0 to 2. A higher score of FMA-UE indicated a higher level of upper limb motor control.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Jacket Test (JT)
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Jacket Test is one of the items in the Physical Performance Test.
The subject is required to don a jacket or a cardigan sweater such that it is straight on his or her shoulders, and then remove it completely.
The time for completing the task is recorded.(Rueben
DB et al, 1990) This Jacket Test (JT) can be used to evaluate the functional mobility of the upper limbs as the test involves abduction of the shoulder joint, flexion and extension of the elbow joint and gripping with the hands.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Maximal Voluntary Contraction (MVC)-Peak Torque
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
The force data would be recorded by the self-made load cell.
And the mean value peak torque of the joint would be calculated by the force and the length from the wrist joint to the head of 3rd metacarpal.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Action Research Arm Test (ARAT)
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
ARAT will be used to assess the 4 aspects of upper limb function(grasp, grip, pinch and gross arm movement).
This scale is consistent of 19 items.
The quality of performance on each item is rated from 0-3, so the score of ARAT is ranged from 0-57.
The score of rasp, grip, pinch and gross arm movement sub-scale are combined to compute the total score.
The scores for the 15 tasks will be summed and then averaged to yield the mean functional ability score.
A higher ARAT score indicated a higher upper limb motor function.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
The Range of Motion (ROM) of Upper Limb Joints
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
With 0° shoulder flexion and 90° elbow flexion, the forearm and wrist will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for wrist flexion/extension. With 90° shoulder flexion and 0° elbow flexion, the forearm will be placed in a neutral position in the relaxed phase. When the task begins, the subjects will be asked to perform the full range of motion for elbow flexion/extension. All the subjects will be requested to perform their joint ROM to the best of their abilities. |
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Motor Activity Log (MAL)
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
The MAL questionnaire will be used to assess how frequently and how well a person uses the paretic upper limb in 30 activities of daily life in a semi-structured interview.
Based on a six-point ordinal scale, subjects will be required to rate (1) the amount of use (AOU), and (2) the quality of movement (QOM) when performing these 30 tasks in real life situations.
Each task was rated from 0 to 5. The score of the 30 activities of daily life were combined to compute the total score of MAL-AOU and MAL-QOM, respectively.
Hence, the total score of AOU and QOM component were rated from 0 to 150.
The higher MAL-AOU score indicated a higher frequency use of the paretic upper limb, and the higher MAL-QOM score indicated a higher movement quality of the paretic upper limb.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Chinese Version of Community Integration Measure (CIM)
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
The Chinese version of CIM was used to assess the level of community integration of the subjects.
The CIM-C has been shown to have good internal consistency and good test-retest reliability for people with stroke .
CIM has 10 items, each item rate from 1-5, giving a minimum score of 10 to a maximum of 50.
A higher score indicated a higher level of community integration.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Maximal Voluntary Contraction (MVC)-Cocontraction Ratio
Časové okno: Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
EMG signal of Radial Carpi Extensor and Ulnar Carpi Flexor for both affected and unaffected side would be recorded by the surface EMG electrodes when asked the subjects to perform the MVC of wrist extension and flexion for 5s in each trial.
Each movement would perform 3 times.
The data of the 3 trials will be averaged.
The co-contraction ratio would be calculated by the iEMG area of antagonist to total (agonist+antagonist), which would be captured for 0.5s from the window began at 0.25s before and ended at 0.25s after the peak value of MVC.
|
Pre-intervention, Mid-intervention (4 weeks), Post-intervention (8 weeks), Follow-up 1 month (12 weeks), Follow-up 3 months (20 weeks)
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- HMRF_SNg
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Task-orientated training
-
Federal University of ParaíbaNáborParkinsonova choroba | Porucha kognice | EEG s abnormálně pomalými frekvencemiBrazílie
-
University of CincinnatiNeznámý
-
University of AmericasAktivní, ne náborKřehkost | Funkční pohybová poruchaChile
-
Trinitas Comprehensive Cancer CenterAptium Oncology Research NetworkNeznámýRakovina prsuSpojené státy
-
Medical University of ViennaMedical University of GrazZatím nenabírámeSrdeční výdej | Hemodynamické měření | NeinvazivníRakousko
-
Florida State UniversityNational Institute of Mental Health (NIMH); National Institutes of Health (NIH)Dokončeno
-
Instituto Nacional de Cardiologia Ignacio ChavezNeznámý
-
Gazi UniversityDokončeno
-
The Hong Kong Polytechnic UniversityAktivní, ne náborMírná kognitivní poruchaFilipíny