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OsteoarthritisNCT06901024

Effects of Neuromobilization, Tendon Gliding, and Robotic Glove-Assisted Exercises on Hand Osteoarthritis

A study testing Tendon Gliding Exercise, Neuromobilization Exercise and Robotic Assitive Exercise in people with Osteoarthritis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The 2018 update of the EULAR recommendations highlighted that exercise reduces pain and improves functionality in patients with hand OA. This study aimed to investigate the effects of neuromobilization, tendon gliding and robotic glove-assisted exercises on pain, grip strength and hand function in patients with hand… Read more about this study

Who is it for?
Ages 45 to 87 years
Conditions the study is for
Osteoarthritis
What is being tested?
Tendon Gliding Exercise, Neuromobilization Exercise and Robotic Assitive Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Aug 2022to 10 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 87 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients were diagnosed with primary hand OA by an orthopedics and traumatology specialist based on the ACR diagnostic criteria.
  • Aged 45 to 87 years

Who cannot join

  • Individuals were excluded from the study if they had a history of major psychiatric disorders, malignancies, systemic or rheumatologic diseases, severe hand trauma or surgery to the hand region within the past six months, prior intra-articular steroid or hyaluronic acid injections into the hand joints, collagen tissue disorders, peripheral vascular diseases, or a history of neuropathy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

    Gaziantep, None Selected, 27144

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Neuromobilization, Tendon Gliding, and Robotic Glove-Assisted Exercises on Pain, Grip Strength, and Hand Function in Patients With Hand Osteoarthritis

The 2018 update of the EULAR recommendations highlighted that exercise reduces pain and improves functionality in patients with hand OA. This study aimed to investigate the effects of neuromobilization, tendon gliding and robotic glove-assisted exercises on pain, grip strength and hand function in patients with hand osteoarthritis (OA).

Read the detailed description

Osteoarthritis (OA) is a chronic musculoskeletal disorder, and its prevalence increases with age. OA is the most common form of arthritis and is associated with reduced hand functionality and grip strength, increased pain and stiffness, and diminished quality of life. The European League Against Rheumatism (EULAR), the Osteoarthritis Research Society International (OARSI), and the American College of Rheumatology (ACR) have published guidelines for the management of hand OA. The 2018 update of the EULAR recommendations highlighted that exercise reduces pain and improves functionality in patients with hand OA. Previously, strengthening and normal range of motion exercises have been shown to improve grip strength compared to placebo. Moreover, a 2017 Cochrane review reported that interventions involving strengthening, flexibility, stretching, and ROM exercises, either individually or in combination, effectively reduce pain, improve grip strength, alleviate joint stiffness, and enhance functionality in patients with OA.

Among various exercise options, tendon gliding exercises and neuromobilization exercises have been increasingly used in recent years. Neural mobilization aims to restore the balance between neural structures and their surrounding mechanical interfaces, thereby reducing internal neural pressure and facilitating optimal physiological function. When used in combination with conventional treatments, tendon gliding exercises were found to be more effective than nerve gliding exercises in patients with carpal tunnel syndrome.

With technological advancements, the use of robotic assistive devices has become increasingly common in rehabilitation. Robotic devices are primarily used to improve upper limb functionality in neurological conditions, particularly in stroke survivors. These devices assist patients in implementing exercise programs. The use of robotic devices in patients with neurological disorders has been demonstrated to produce positive effects on the central nervous system and sensorimotor deficits. In patients with knee OA, wearable robotic assistive devices have been shown to significantly improve stair-climbing ability and reduce knee pain.

Few studies investigating the efficacy of robotic rehabilitation in hand OA are available in the literature. Research comparing the effects of robotic assistive devices with other treatment methods is still in its early stages. It has been noted by the OARSI that, due to the methodological limitations across studies, and the clinical heterogeneity between studies, it is difficult to provide any reliable practical recommendations for the choice of appropriate therapy in patients with hand OA. Considering the existing gaps in the literature and the recommended research priorities, this study aimed to investigate the effects of neuromobilization, tendon gliding exercises, and the use of a wearable robotic assistive device on pain, grip strength, and hand function in patients with hand OA.

Conditions
Osteoarthritis
Being tested
Tendon Gliding Exercise, Neuromobilization Exercise, Robotic Assitive Exercise, Conventional Exercises
Keywords
Osteoarthritis, Neuromobilization, Tendon gliding, Robotic Assistive Device
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tendon Gliding ExerciseOther

    Tendon gliding exercises were performed for both hands in a sequential manner, with 20 repetitions in 3 sets. The exercises started with fingers and wrist positioned in extension. Subsequent positions included the hook position, full fist position, MCP joint at 90° flexion with finger extension, and MCP and proximal interphalangeal (PIP) joints at 90° flexion positions, with a 5-second hold at each position. During the TG exercises, the hand and fingers are brought to five different positions

  • Neuromobilization ExerciseOther

    The neuromobilization exercises included median, radial and ulnar nerve mobilizations. For median nerve mobilization, the patient's wrist was placed in extension, the shoulder in 90° abduction, the forearm in supination, the elbow extended, and the head positioned in lateral flexion toward the same side. For radial nerve mobilization, the wrist was initially placed in flexion and ulnar deviation, the forearm in pronation, with the elbow extended, and the head positioned in lateral flexion toward the same side. For ulnar nerve mobilization, the wrist was positioned in extension and radial deviation, the elbow fully flexed, the forearm in pronation, the shoulder in 90°abduction, and the head in lateral flexion toward the same side. The head was then moved into lateral flexion toward the opposite side while extending the elbow. The neuromobilization protocol was performed in 4 sets of 10 repetitions, with a 5-second hold for each movement.

  • Robotic Assitive ExerciseOther

    The robotic glove set used in this study weighs 497 grams, powered by a battery weighing 170 grams that provides a 5 V voltage and 1 A current. Made from elastic fabric, the glove wraps around all fingers on both the dorsal and palmar sides. The palm section of the glove is hollow. The device features four Velcro straps: one at the wrist, one across the web space between the thumb and index finger, one between the second and third fingers, and one between the fourth and fifth fingers, securing the inner side of the wrist. The robotic glove facilitates passive joint movements through pneumatic air pressure. The device offers several benefits, including proprioceptive stimulation, visual input, increased functional independence, pain and edema reduction, enhanced lymphatic and blood circulation, improved coordination and hand dexterity, as well as increased grasp and compression strength.

  • Conventional ExercisesOther

    Wrist extensor exercise, wrist radial deviation exercise, and wrist flexor exercise were perfomed using a 1-kg dumbbell. Holding the 1-kg dumbbell against gravity for 10 seconds, with the shoulder flexed at 90°, elbow extended, and forearm in pronation position. Squeezing exercise with a green soft ball (Thera-Band; diameter: 5 cm); the ball was squeezed for 10 seconds, followed by relaxing. Pushing a blue Pilates ball (Thera-Band; diameter: 20 cm) against the wall with fingers in extension position. Squeezing a black Pilates ring (Thera-Band; diameter: 38 cm) with the fingers, while the MCP joints are in extension and the wrist in a neutral position.

Study groups in NCT06901024
Study groupRoleWhat they receive
Tendon gliding groupExperimentalThe tendon gliding exercises were applied after conventional exercises.
Receives: Other: Tendon Gliding Exercise; Other: Conventional Exercises
NeuromobilizationExperimentalThe neuromobilization were applied after conventional exercises.
Receives: Other: Neuromobilization Exercise; Other: Conventional Exercises
Robotic assisted exercisesExperimentalThe robotic glove-assisted (RGA) exercise group performed passive movements for 60 minutes using soft robotic gloves (Masmel Health, Turkey), in combination with conventional exercises.
Receives: Other: Robotic Assitive Exercise; Other: Conventional Exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Australian-Canadian Hand Osteoarthritis Index

    The Australian-Canadian Hand Osteoarthritis Index (AUSCAN) is a self-report tool commonly used for the assessment of hand functionality in hand OA. The AUSCAN includes a total of 15 items measuring pain (5 items; 0 to 20 points), stiffness (1 item; 0 to 4 points), and function (9 items; 0 to 36 points) during the preceding 48 hours. Total possible scores range from 0 to 60 points

    Measured: 8 weeks

  2. Jebsen-Taylor Hand Function Test

    The Jebsen-Taylor Hand Function Test (JTHFT) is used to assess fine and gross motor hand function when performing activities of daily living (ADLs) and to measure the speed at which they perform the test tasks. The JTHFT is a valid and reliable tool and consists of 7 tasks, including writing, turning over cards, picking up objects, stacking checkers, simulated feeding, and moving light and heavy objects. Participants were asked to perform each task separately for each hand, and the time taken for each task was recorded using a stopwatch

    Measured: 8 weeks

  3. Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire

    The Quick-DASH short form consists of a total of 11 questions that ask about an individual's neurological symptoms, pain, sleep disturbances and their ability to work and perform certain activities in the previous week. Each item is assigned a score between 1 and 5: 1 (no difficulty), 2 (mild difficulty), 3 (moderate difficulty), 4 (severe difficulty), 5 (unable). Total possible scores range from 0 (no disability) to 100 (most severe disability). The total score is scaled between 0 (no disability) and 100 (maximum symptoms and disability)

    Measured: 8 weeks

  4. Pain Intensity

    The Visual Analog Scale (VAS) is a simple, self-administered tool. It consists of a 10-cm line, with the left end representing no pain and the right end representing worst possible pain. Individuals rate their pain intensity by marking a point on VAS, which is scored from 0 to 10.The point marked by the patient on the 10-cm line was measured using a ruler, and the corresponding distance in centimeters was recorded.

    Measured: 8 weeks

Secondary outcomes (2)
  1. Static grip strength

    A hydraulic hand dynamometer (Jamar, China) was used to measure the static grip strength of the participants. The hydraulic hand dynamometer is a widely used, reliable device for assessing grip strength. Measurements were obtained while the participants were seated upright on a chair, with the MCP joints in a flexion position, elbow flexed at 90°, forearms parallel to the ground, shoulders in adduction, and feet in full contact with the floor. Each measurement was repeated three times, and the highest value in kilograms was noted.

    Measured: 8 weeks

  2. Perceived pain

    The perceived pain was assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ).The SF-MPQ was designed as a less time-consuming tool than the original MPQ that allows patients to describe their pain intensity in a relatively short period. The tool consists of two subscales with a total of 15 pain descriptors, including 11 sensory descriptors and 4 affective descriptors. Each word is rated on an intensity scale from 0 (none) to 3 (severe).

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2025
  2. Study start23 Aug 2022
  3. Primary completion3 Nov 2023
  4. Study completion10 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The patients were divided into three groups: neuromobilization, tendon gliding, and robotic glove-assisted exercise group.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06901024
Sponsor's protocol ID
2022/081
Status last verified
Mar 2025
First submitted
23 Mar 2025
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kloppenburg M, Kroon FP, Blanco FJ, Doherty M, Dziedzic KS, Greibrokk E, Haugen IK, Herrero-Beaumont G, Jonsson H, Kjeken I, Maheu E, Ramonda R, Ritt MJ, Smeets W, Smolen JS, Stamm TA, Szekanecz Z, Wittoek R, Carmona L. 2018 update of the EULAR recommendations for the management of hand osteoarthritis. Ann Rheum Dis. 2019 Jan;78(1):16-24. doi: 10.1136/annrheumdis-2018-213826. Epub 2018 Aug 28.

    PubMed 30154087
  • Stoffer-Marx MA, Klinger M, Luschin S, Meriaux-Kratochvila S, Zettel-Tomenendal M, Nell-Duxneuner V, Zwerina J, Kjeken I, Hackl M, Ohlinger S, Woolf A, Redlich K, Smolen JS, Stamm TA. Functional consultation and exercises improve grip strength in osteoarthritis of the hand - a randomised controlled trial. Arthritis Res Ther. 2018 Nov 9;20(1):253. doi: 10.1186/s13075-018-1747-0.

    PubMed 30413191
  • Horng YS, Hsieh SF, Tu YK, Lin MC, Horng YS, Wang JD. The comparative effectiveness of tendon and nerve gliding exercises in patients with carpal tunnel syndrome: a randomized trial. Am J Phys Med Rehabil. 2011 Jun;90(6):435-42. doi: 10.1097/PHM.0b013e318214eaaf.

    PubMed 21430512
  • Mehrholz J, Pohl M, Platz T, Kugler J, Elsner B. Electromechanical and robot-assisted arm training for improving activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2018 Sep 3;9(9):CD006876. doi: 10.1002/14651858.CD006876.pub5.

    PubMed 30175845
  • Pedersini P, Valdes K, Cantero-Tellez R, Cleland JA, Bishop MD, Villafane JH. Effects of Neurodynamic Mobilizations on Pain Hypersensitivity in Patients With Hand Osteoarthritis Compared to Robotic Assisted Mobilization: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2021 Feb;73(2):232-239. doi: 10.1002/acr.24103. Epub 2021 Jan 3.

    PubMed 31675184
  • Villafane JH, Valdes K, Imperio G, Borboni A, Cantero-Tellez R, Galeri S, Negrini S. Neural manual vs. robotic assisted mobilization to improve motion and reduce pain hypersensitivity in hand osteoarthritis: study protocol for a randomized controlled trial. J Phys Ther Sci. 2017 May;29(5):801-806. doi: 10.1589/jpts.29.801. Epub 2017 May 16.

    PubMed 28603349

Questions about this trial

What is this clinical trial studying?

A study testing Tendon Gliding Exercise, Neuromobilization Exercise and Robotic Assitive Exercise in people with Osteoarthritis, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Australian-Canadian Hand Osteoarthritis Index (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06901024, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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