- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07800260
Graded Motor Imagery in Carpal Tunnel Syndrome
Is There an Advantage to Incorporating a Central Nervous System-targeted Intervention Within an Exercise Program for Individuals Diagnosed With Carpal Tunnel Syndrome? A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zeynep Yıldız Kızkın
- Numéro de téléphone: +905346945085
- E-mail: pt.zeynepyildiz@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- mild to moderate unilateral CTS based on the Bland classification of electrodiagnostic testing ;
- positive Phalen or Tinel tests;
- symptoms such as paresthesia and pain associated with CTS that last longer than 3 months;
- patients aged 30-60 years (when CTS becomes more prevalent);
- patients who achieved a minimum score of 24 on the Mini-Mental State Examination (MMSE).
Exclusion Criteria:
- bilateral CTS;
- history of prior CTS surgery;
- clinical indicators of cervical radiculopathy or polyneuropathy;
- pregnancy or cognitive impairment;
- the presence of orthopedic, neurological, or functional problems on the unaffected side that could affect hand function (e.g., history of trauma or surgery, peripheral nerve injury, tendinopathy, tenosynovitis, trigger finger, arthritis, sequelae of a fracture, etc.);
- receipt of any conservative treatment for CTS within the last month.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Graded Motor Imagery
Each patient in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, progressive neurodynamic exercises, and nighttime resting splints.
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GMI includes three stages. GMI program will span over 6 weeks. The first 2 weeks will focus on lateralization, followed by 2 weeks of motor imagery, and the final 2 weeks will involve mirror therapy. Lateralization: Patients will be asked to differentiate whether the hands shown in the Recognise™ Hand application belongs to the right or left side of their body. Motor Imagery: Patients will be instructed to imagine slowly and smoothly moving their affected extremities to the posture depicted in the photos in the Recognise™ Hand application and then returning to the starting position. Mirror Therapy: Using a mirror measuring 300 x 300 x 300 mm³ placed between the upper extremities, patients will be instructed to progressively move only their unaffected extremity, then their affected extremity, and finally both extremities.
The progressive neurodynamic exercises involved holding each position for 5 seconds.
Each session included two sets of 10 repetitions (2×10).
The treatment lasted for 30-minute sessions, conducted twice weekly over a total of 6 weeks.
The night splint was fitted with a wrist splint that keeps the wrist in a neutral position, permits finger flexion, maintains the wrist within a 0°-5° extension range, and ends just distal to the distal palmar crease.
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Comparateur actif: Progressive Neurodynamic Exercises
Each patient in the progressive neurodynamic exercises group will receive a treatment protocol consisting of progressive neurodynamic exercises and nighttime resting splints.
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The progressive neurodynamic exercises involved holding each position for 5 seconds.
Each session included two sets of 10 repetitions (2×10).
The treatment lasted for 30-minute sessions, conducted twice weekly over a total of 6 weeks.
The night splint was fitted with a wrist splint that keeps the wrist in a neutral position, permits finger flexion, maintains the wrist within a 0°-5° extension range, and ends just distal to the distal palmar crease.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Délai: Baseline
|
DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects.
Examples include turning a doorknob, changing a light bulb, and cutting food.
Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
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Baseline
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Disabilities of the Arm, Shoulder, and Hand (DASH)
Délai: After the 6-week intervention
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DASH is a 30-item self-report tool assessing upper-extremity disability and symptoms, including daily activities, pain, numbness, joint stiffness, weakness, sleep issues, and psychological effects.
Examples include turning a doorknob, changing a light bulb, and cutting food.
Scores range from 0 to 100; higher scores indicate more severe symptoms and impairment.
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After the 6-week intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mini examen de l'état mental
Délai: Ligne de base
|
Le Mini-Mental State Examination (MMSE) sera utilisé pour évaluer l'état cognitif des patients.
Il se compose de 11 questions et est évalué sur une échelle de 30 points.
Un score entre 24 et 30 est considéré comme normal, 18-23 indique une déficience cognitive légère et un score de 17 ou moins indique une démence sévère.
Le MMSE évalue l'orientation, la mémoire, l'attention, le calcul, le rappel, le langage, la fonction motrice, la perception et les capacités visuospatiales.
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Ligne de base
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Mini Mental State Examination
Délai: After the 6-week intervention
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The Mini-Mental State Examination (MMSE) will be used to assess the cognitive status of patients.
It consists of 11 questions and is evaluated on a scale of 30 points.
A score between 24-30 is considered normal, 18-23 indicates mild cognitive impairment, and a score of 17 or below is indicative of severe dementia.
The MMSE assesses orientation, memory, attention, calculation, recall, language, motor function, perception, and visuospatial abilities.
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After the 6-week intervention
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Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Délai: Baseline
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A patient-reported assessment uses a 5-point Likert scale with two subscales: the 11-item Symptom Severity Scale (CTSQ-S) for symptom intensity like numbness and pain, and the 8-item Functional Status Scale (CTSQ-F) for ADL ability such as writing and dressing.
Higher scores mean more severe symptoms and impairment.
The BCTQ shows high reliability, validity, and sensitivity to clinical changes.
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Baseline
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Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Délai: After the 6-week intervention
|
A patient-reported assessment uses a 5-point Likert scale with two subscales: the 11-item Symptom Severity Scale (CTSQ-S) for symptom intensity like numbness and pain, and the 8-item Functional Status Scale (CTSQ-F) for ADL ability such as writing and dressing.
Higher scores mean more severe symptoms and impairment.
The BCTQ shows high reliability, validity, and sensitivity to clinical changes.
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After the 6-week intervention
|
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The Semmes-Weinstein Monofilament Test
Délai: Baseline
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The assessment used a monofilament test (0.49-0.96), known for high sensitivity in diagnosing CTS.
Sensory thresholds were checked at the radial tips of the thumbs, index, middle, and ring fingers.
The monofilament was applied perpendicularly to the dorsal finger pads with eyes closed and the wrist in a neutral position.
Pressure was applied for 1 to 1.5 seconds until slight bending of the filament.
Lower readings indicate better sensory function; higher readings suggest worse light touch perception.
A gauge of 2.83 grams is the normal threshold, while 3.22 grams or higher indicates moderate-to-severe sensory impairment in CTS.
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Baseline
|
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The Semmes-Weinstein Monofilament Test
Délai: After the 6-week intervention
|
The assessment used a monofilament test (0.49-0.96), known for high sensitivity in diagnosing CTS.
Sensory thresholds were checked at the radial tips of the thumbs, index, middle, and ring fingers.
The monofilament was applied perpendicularly to the dorsal finger pads with eyes closed and the wrist in a neutral position.
Pressure was applied for 1 to 1.5 seconds until slight bending of the filament.
Lower readings indicate better sensory function; higher readings suggest worse light touch perception.
A gauge of 2.83 grams is the normal threshold, while 3.22 grams or higher indicates moderate-to-severe sensory impairment in CTS.
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After the 6-week intervention
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Purdue Pegboard Test
Délai: Baseline
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The Purdue Pegboard consists of 50 holes in two columns, with pins, washers, and sleeves in four recesses at the top.
Patients sat in front of the apparatus and performed four tests: the dominant hand, non-dominant hand, two-hand, and assembly test.
For the hand tests, they inserted pins into holes with their hands for 30 seconds each; the two-hand test used both hands.
In the assembly test, they placed materials in order: pin → washer → collars → washer within 60 seconds.
Each test was repeated three times, and scores were averaged.
This test assesses fine motor skills, coordination, finger dexterity, hand-eye coordination, and small object manipulation; lower scores indicate poorer hand skills.
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Baseline
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Purdue Pegboard Test
Délai: After the 6-week intervention
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The Purdue Pegboard consists of 50 holes in two columns, with pins, washers, and sleeves in four recesses at the top.
Patients sat in front of the apparatus and performed four tests: the dominant hand, non-dominant hand, two-hand, and assembly test.
For the hand tests, they inserted pins into holes with their hands for 30 seconds each; the two-hand test used both hands.
In the assembly test, they placed materials in order: pin → washer → collars → washer within 60 seconds.
Each test was repeated three times, and scores were averaged.
This test assesses fine motor skills, coordination, finger dexterity, hand-eye coordination, and small object manipulation; lower scores indicate poorer hand skills.
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After the 6-week intervention
|
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The Two-Point Discrimination Test
Délai: Baseline
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The two-point discrimination threshold was evaluated using an esthesiometer applied to the pulp of the thumb, index, and middle fingers.
During the evaluation, participants' eyes remained closed, and light stimuli, consisting of either one or two points, were randomly presented along the longitudinal axis of the fingers.
The procedure began at a distance of 5 mm, with 10 trials conducted at each specified interval.
If the participant failed to achieve at least seven correct responses, the distance was increased by 1 mm, and the test was repeated.
The discrimination threshold was defined as the smallest distance at which at least seven out of ten responses were correct.
Testing was discontinued at a maximum distance of 15 mm, with values below 6 mm considered within normal limits.
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Baseline
|
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The Two-Point Discrimination Test
Délai: After the 6-week intervention
|
The two-point discrimination threshold was evaluated using an esthesiometer applied to the pulp of the thumb, index, and middle fingers.
During the evaluation, participants' eyes remained closed, and light stimuli, consisting of either one or two points, were randomly presented along the longitudinal axis of the fingers.
The procedure began at a distance of 5 mm, with 10 trials conducted at each specified interval.
If the participant failed to achieve at least seven correct responses, the distance was increased by 1 mm, and the test was repeated.
The discrimination threshold was defined as the smallest distance at which at least seven out of ten responses were correct.
Testing was discontinued at a maximum distance of 15 mm, with values below 6 mm considered within normal limits.
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After the 6-week intervention
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Grip Strength
Délai: Baseline
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Grip strength was measured using a hand dynamometer.
The participant sat comfortably with shoulder abducted, elbow at 90°, and forearm neutral.
The wrist was between 0° and 30° extension.
Each hand was tested three times with one-minute rests, and the average was recorded.
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Baseline
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Grip Strength
Délai: After the 6-week intervention
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Grip strength was measured using a hand dynamometer.
The participant sat comfortably with shoulder abducted, elbow at 90°, and forearm neutral.
The wrist was between 0° and 30° extension.
Each hand was tested three times with one-minute rests, and the average was recorded.
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After the 6-week intervention
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Zeynep Yıldız Kızkın, Artvin Coruh University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Graded Motor Imagery in CTS
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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