NCT06627296

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

October 1, 2024

Last Update Submit

August 9, 2025

Conditions

Keywords

Scapholunate InstabilityNeuromuscular Electrical StimulationIsokinetic Muscle StrengthProprioceptive SensationReaction TimeFunctionality

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

EXPERIMENTAL

The 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.

Other: Exercise TrainingDevice: Neuromuscular Electrical Stimulation

Exercise Training Group (Control Group)

EXPERIMENTAL

Patients 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.

Other: Exercise Training (Control Group)

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.

Neuromuscular Electrical Stimulation Group combined with Exercise Training

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.

Exercise Training Group (Control Group)

Neuromuscular Electrical Stimulation

Neuromuscular Electrical Stimulation Group combined with Exercise Training

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

İstanbul University İstanbul Faculty of Medicine

Istanbul, Çapa, Fatih, Turkey (Türkiye)

Location

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.

MeSH Terms

Interventions

ExerciseControl Groups

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Semra Topuz, Prof.Dr.

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Arzu Dağ, Ph.D Student

    Hacettepe University

    PRINCIPAL INVESTIGATOR

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
Model Details: Two groups with a intervention group including Nmes and exercise therapy and a control group including exercise therapy
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

Locations