The Effect of Combined Exercise and NMES on Strength, Proprioception and Reaction Time in Scapholunate Instability
1 other identifier
interventional
44
1 country
2
Brief Summary
In our study, which we conducted to investigate the effect of exercise training combined with neuromuscular electrical stimulation on muscle strength, proprioceptive sensation, reaction time and functionality in patients with scapholunate (SL) instability, individuals with SL instability who meet the inclusion criteria and volunteer to participate in the study will participate. After the approval of the ethics committee, it is planned to include as many individuals with SL instability as the number to be obtained following the power analysis to be performed as a result of the pilot study. The pain of the subjects will be evaluated with the VAS pain scale during rest-activity-exercise. All participants will be evaluated with the isokinetic cybex device for isokinetic muscle strength of the wrist, grip strength with the JAMAR hand held dynometer, NEH evaluation: goniometer, proprioceptive sensation with ACUMAR and isokinetic device, reaction time with blazepod trainer, wrist pain transfer with a digital scale, assessment of upper extremity functional status: pwre (patient rated wrist evaluation), modified mayo wrist score, DASH, EL20 questionnaire, SF-12 questionnaires. In this randomized controlled study, the first group will receive NMES and exercise training 3 days a week for a total of 8 weeks and the other group will receive only exercise training. The evaluations will be done at the beginning and twice in total after the 8-week rehabilitation program. The exercises given to the patients in both groups will be similar for 8 weeks and they will receive a total of 24 sessions of exercise programs with 15 repetitions per day, 3 days a week, accompanied by a physiotherapist. Both groups will also be given home exercises to continue at home. NMES and exercise trainings will be applied in such a way that activation of SL-friendly extensor carpi radialis longus (ECRL), extensor carpi radialis brevis (ECRB), flexor carpi radialis (FCR), and abductor pollicis longus (APL) muscles will be followed by inhibition of non-friendly extensor carpi ulnaris (ECU). After the completion of the thesis, it is planned to add to the literature by examining the effects of exercise training combined with NMES on muscle strength, proprioceptive sensation, reaction time and functionality in individuals diagnosed with SL instability and the superiorities, if any, between the methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 8, 2024
CompletedFirst Submitted
Initial submission to the registry
October 1, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 9, 2025
CompletedAugust 12, 2025
August 1, 2025
3 months
October 1, 2024
August 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Hand Isokinetic Muscle Strength Evaluation
It will be evaluated with the Isokinetic Cybex device. At 60/90/ angular velocities, the extensor-flexor peak torque force / work produced by the muscle will be evaluated concentrically.
1 day before intervention
Hand Isokinetic Muscle Strength Evaluation
It will be evaluated with the Isokinetic Cybex device. At 60/90/ angular velocities, the extensor-flexor peak torque force / work produced by the muscle will be evaluated concentrically.
1 day of discharge
Grip Strength Evaluation
It will be evaluated with the JAMAR hand held dynamometer
1 day before intervention
Grip Strength Evaluation
It will be evaluated with the JAMAR hand held dynamometer
1 day of discharge
Wrist Proprioception Evaluation
It will be evaluated with the Isokinetic Cybex Device and ACUMAR device The hand will be brought to the target angle value of 30 degrees extension or 30 degrees flexion with the help of a physiotherapist and will be waited for approximately 5 seconds. After the patient learns, he/she will be asked to do it himself/herself with his/her eyes closed. After the movement is repeated 3 times in a row, the participant will be asked to actively apply the determined target extension movement to the same extremity. The difference between the target angle and the measured angle. The difference between the target angle and the measured angle will be recorded as the margin of error.
1 day before intervention
Wrist Proprioception Evaluation
It will be evaluated with the Isokinetic Cybex Device and ACUMAR device The hand will be brought to the target angle value of 30 degrees extension or 30 degrees flexion with the help of a physiotherapist and will be waited for approximately 5 seconds. After the patient learns, he/she will be asked to do it himself/herself with his/her eyes closed. After the movement is repeated 3 times in a row, the participant will be asked to actively apply the determined target extension movement to the same extremity. The difference between the target angle and the measured angle.The difference between the target angle and the measured angle will be recorded as the margin of error.
1 day of discharge
Pain Evaluation: Visual Analog Scale
It contains 10 cm line that should be assigned according to perceived pain intensity at rest, during activity and while exercising.
1 day before intervention
Pain Evaluation: Visual Analog Scale
It contains 10 cm line that should be assigned according to perceived pain intensity at rest, during activity and while exercising.
1 day of discharge
Evaluation of Reaction Time
Upper extremity reaction time evaluation will be performed with the reaction speed measurement and exercise set Blazepod Trainer (Blazepod Trainer Device, Play Coyotta Ltd. Tel Aviv Israel) device. Individuals will be asked to turn off the 5 LEDs placed on the table in front of them as quickly as possible with one hand in the sitting position. Both hands will be evaluated. The number of LEDs extinguished in 30 seconds (number), the unit extinguishing time (msec) and the number of LEDs missed when the LEDs extinguished after a 5-second waiting period will be recorded. Measurements will be made on both hands.
1 day before intervention
Evaluation of Reaction Time
Upper extremity reaction time evaluation will be performed with the reaction speed measurement and exercise set Blazepod Trainer (Blazepod Trainer Device, Play Coyotta Ltd. Tel Aviv Israel) device. Individuals will be asked to turn off the 5 LEDs placed on the table in front of them as quickly as possible with one hand in the sitting position. Both hands will be evaluated. The number of LEDs extinguished in 30 seconds (number), the unit extinguishing time (msec) and the number of LEDs missed when the LEDs extinguished after a 5-second waiting period will be recorded. Measurements will be made on both hands.
1 day of discharge
Weight-Bearing Test
Test protocol: The subject will be asked to apply as much pressure as possible with the extended elbow and wrist on a digital scale. The subjects will perform 3 trials and the average value will be recorded in kilograms and will be compared with the weight transfer test of the unaffected hand, which is determined as a normative value for maximum weight-bearing capacity.
1 day before intervention
Weight-Bearing Test
Test protocol: The subject will be asked to apply as much pressure as possible with the extended elbow and wrist on a digital scale. The subjects will perform 3 trials and the average value will be recorded in kilograms and will be compared with the weight transfer test of the unaffected hand, which is determined as a normative value for maximum weight-bearing capacity.
1 day of discharge
Secondary Outcomes (10)
Patient Rated Wrist Evaluation (PWRE)
1 day before intervention
Patient Rated Wrist Evaluation (PWRE)
At the time of discharge
Modified Mayo Wrist Score
1 day before intervention
Modified Mayo Wrist Score
At the time of discharge
Quick DASH
1 day before intervention
- +5 more secondary outcomes
Study Arms (2)
Neuromuscular Electrical Stimulation Group combined with Exercise Training
EXPERIMENTALThe intervention group will receive neuromuscular electrical stimulation combined with exercise training. The group will also be given home exercises to continue at home. Individuals in the NMES group will undergo NMES application accompanied by a physiotherapist for a total of 24 sessions of 15 repetitions 3 days a week for 8 weeks and then exercise programs will be performed face-to-face. On the other days, patients will be asked to perform 3 sets of 15 repetitions every day as home exercises. Exercise training includes intrinsic and extrinsic muscle strengthening, wrist stabilization exercises, dart exercises, wrist neuromuscular exercises using different materials, reactive muscle control, perturbation exercises.
Exercise Training Group (Control Group)
EXPERIMENTALPatients in the control group will have face-to-face exercise programs with a physiotherapist. Exercise training includes intrinsic and extrinsic muscle strengthening, wrist stabilization exercises, dart exercises, wrist neuromuscular exercises using different materials, reactive muscle control, perturbation exercises.
Interventions
Individuals in the NMES group will have a total of 24 sessions of NMES application with 15 repetitions 3 days a week for 8 weeks and then exercise programs will be performed face-to-face. They will also be given home exercises to continue at home. In the NMES group, NMES training will be performed for extensor carpi radialis longus (ECRL), extensor carpi radialis brevis (ECRB), abductor pollicis longus (APL), flexor carpi radialis (FCR) muscles. The pencil electrode will be used to stimulate the ECRL, ECRB, FCR and APL muscles in such a way that 30+30+30=90 contractions will be obtained from each muscle. According to the morphologic characteristics of each muscle, different current and will be applied. P11th program to ECRL and APL : 65 Hz. 200 μs, P13th program to ECRB and FCR 50 Hz, 200 μs will be applied. Exercises includes intrinsic and extrinsic muscle strengthening, stabilization exercises and dart exercises, wrist neuromuscular exercises and perturbation exercises.
Patients in the control group will have face-to-face exercise programs with a physiotherapist for a total of 24 sessions of 15 repetitions 3 days a week for 8 weeks. Exercises will be performed 3 days a week with a physiotherapist. On the other days, patients will be asked to perform 3 sets of 15 repetitions every day as home exercises. Exercise training includes intrinsic and extrinsic muscle strengthening, wrist stabilization exercises, dart exercises, wrist neuromuscular exercises using different materials, reactive muscle control, perturbation exercises. Exercises will be at the limit of pain. Until the 6th month, overloading, strong gripping, weight transfer, rotations and lifting heavy objects should be avoided. Rehabilitation with functional range of motion is important. Exercises will be performed with a physiotherapist 3 days a week. On the other days, patients will be asked to perform 3 sets of 15 repetitions every day as home exercises.
Neuromuscular Electrical Stimulation
Eligibility Criteria
You may qualify if:
- Being between the ages of 18-45
- Applying to the clinic within the last 6 months
- Being diagnosed with scapholunate instability
You may not qualify if:
- Having a history of previous hand/wrist surgery
- Having a neurological or severe systemic disease
- Having any entrapment neuropathy in the upper extremity
- Having any trauma in the upper extremity
- Having a history of reflex sympathetic dystrophy
- Being diagnosed with cervical disc herniation
- Having a psychiatric disorder that will affect cooperation
- Having received training focused on sensory and functional rehabilitation in either hand in the last 6 months
- For any reason, the patient and family do not want to participate in the study or do not comply with the tests.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of Physical Therapy and Rehabilitation, Hacettepe University
Ankara, Sıhhiye Campus Hacettepe University Sıhhiye, Ankara, 06100, Turkey (Türkiye)
İstanbul University İstanbul Faculty of Medicine
Istanbul, Çapa, Fatih, Turkey (Türkiye)
Related Publications (1)
Dag A, Ayik O, Firat T, Sahinkaya T, Topuz S. The effectiveness of NMES-integrated therapy in scapholunate ligament injuries - a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Dec 2;18(1):12. doi: 10.1186/s13102-025-01452-4.
PMID: 41331647DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Semra Topuz, Prof.Dr.
Hacettepe University
- PRINCIPAL INVESTIGATOR
Arzu Dağ, Ph.D Student
Hacettepe University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Blinding was done by ensuring that the participant did not know which group the subject was they were in. Also, the other researcher assessing the measurements did not know which treatment the patients received.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctorate student
Study Record Dates
First Submitted
October 1, 2024
First Posted
October 4, 2024
Study Start
September 8, 2024
Primary Completion
December 20, 2024
Study Completion
August 9, 2025
Last Updated
August 12, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share