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

NCT ID: NCT06901024

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-23

Study Completion Date

2024-01-10

Brief Summary

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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).

Detailed Description

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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

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were divided into three groups: neuromobilization, tendon gliding, and robotic glove-assisted exercise group.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
All assessments were conducted by a single physiotherapist, who was blinded to group allocation.

Study Groups

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Tendon gliding group

The tendon gliding exercises were applied after conventional exercises.

Group Type EXPERIMENTAL

Tendon Gliding Exercise

Intervention Type OTHER

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

Conventional Exercises

Intervention Type OTHER

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.

Neuromobilization

The neuromobilization were applied after conventional exercises.

Group Type EXPERIMENTAL

Neuromobilization Exercise

Intervention Type OTHER

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.

Conventional Exercises

Intervention Type OTHER

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.

Robotic assisted exercises

The robotic glove-assisted (RGA) exercise group performed passive movements for 60 minutes using soft robotic gloves (Masmel Health, Turkey), in combination with conventional exercises.

Group Type EXPERIMENTAL

Robotic Assitive Exercise

Intervention Type OTHER

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 Exercises

Intervention Type OTHER

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.

Interventions

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Tendon Gliding Exercise

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

Intervention Type OTHER

Neuromobilization Exercise

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.

Intervention Type OTHER

Robotic Assitive Exercise

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.

Intervention Type OTHER

Conventional Exercises

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasan Kalyoncu University

OTHER

Sponsor Role lead

Responsible Party

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Serkan Usgu

Head of Physiotherapy Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Serkan Usgu

Role: PRINCIPAL_INVESTIGATOR

Hasan Kalyoncu University

Locations

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Hasan Kalyoncu University, Department of Physiotherapy and Rehabilitation

Gaziantep, None Selected, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30154087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30413191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21430512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30175845 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31675184 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28603349 (View on PubMed)

Other Identifiers

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2022/081

Identifier Type: -

Identifier Source: org_study_id

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