- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Zeynep Yıldız Kızkın
- Telefonnummer: +905346945085
- E-mail: pt.zeynepyildiz@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand (DASH)
Tidsramme: 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.
|
Baseline
|
|
Disabilities of the Arm, Shoulder, and Hand (DASH)
Tidsramme: After the 6-week intervention
|
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.
|
After the 6-week intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mini mental tilstandsundersøgelse
Tidsramme: Baseline
|
Mini-Mental State Examination (MMSE) vil blive brugt til at vurdere patienters kognitive status.
Den består af 11 spørgsmål og bedømmes efter en skala på 30 point.
En score mellem 24-30 betragtes som normal, 18-23 indikerer mild kognitiv svækkelse, og en score på 17 eller derunder indikerer svær demens.
MMSE vurderer orientering, hukommelse, opmærksomhed, beregning, genkaldelse, sprog, motorisk funktion, perception og visuospatiale evner.
|
Baseline
|
|
Mini Mental State Examination
Tidsramme: After the 6-week intervention
|
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.
|
After the 6-week intervention
|
|
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Tidsramme: Baseline
|
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.
|
Baseline
|
|
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Tidsramme: 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.
|
After the 6-week intervention
|
|
The Semmes-Weinstein Monofilament Test
Tidsramme: Baseline
|
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.
|
Baseline
|
|
The Semmes-Weinstein Monofilament Test
Tidsramme: 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.
|
After the 6-week intervention
|
|
Purdue Pegboard Test
Tidsramme: Baseline
|
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.
|
Baseline
|
|
Purdue Pegboard Test
Tidsramme: After the 6-week intervention
|
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.
|
After the 6-week intervention
|
|
The Two-Point Discrimination Test
Tidsramme: Baseline
|
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.
|
Baseline
|
|
The Two-Point Discrimination Test
Tidsramme: 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.
|
After the 6-week intervention
|
|
Grip Strength
Tidsramme: Baseline
|
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.
|
Baseline
|
|
Grip Strength
Tidsramme: After the 6-week intervention
|
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.
|
After the 6-week intervention
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Zeynep Yıldız Kızkın, Artvin Coruh University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Graded Motor Imagery in CTS
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