- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Hong Kong, Hongkong
- The Hong Kong Polytechnic University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: 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
|
Placebo-vergelijker: 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.
|
Placebo-vergelijker: 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.
|
Geen tussenkomst: Control group
No Active intervention
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Fugl Meyer Assessment on Upper Extremity (FMA-UE)
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Jacket Test (JT)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HMRF_SNg
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Task-orientated training
-
KU LeuvenActief, niet wervend
-
King Saud UniversityVoltooidHartinfarct | Chronische beroerte | Middelste cerebrale slagaderslagSaoedi-Arabië
-
National Yang Ming UniversityOnbekendHartinfarct | Ziekte van ParkinsonTaiwan
-
East Carolina UniversityVoltooidGezonde volwassenen | Dubbele taakVerenigde Staten
-
Cairo UniversityWervingDiplegische hersenverlammingEgypte
-
Riphah International UniversityVoltooid
-
The University of Hong KongHealth and Medical Research FundWervingGoed ouder wordenHongkong
-
National Yang Ming UniversityWervingGezond | OuderenTaiwan
-
Afyonkarahisar Health Sciences UniversityWerving
-
Sema BÜĞÜŞAN ORUÇVoltooidCerebrale parese | Fysieke handicap | Hemiplegie Cerebrale Parese | Activiteit, Motor | Deelname, patiënt | DiplegieKalkoen