Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Effects of Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
Diabetic peripheral neuropathy (DPN) will be considered a clinically important complication of diabetes mellitus that may impair sensory function and interfere with the performance of daily activities involving the hands and feet. Sensory deficits may affect tactile perception, object manipulation, foot-related functional tasks, and the ability to interact safely with the surrounding environment.
The purpose of this study will be to investigate the effects of adaptive gamified sensory training combined with conventional physical therapy on sensory function, sensory integration during balance, and hand functional performance in patients with diabetic peripheral neuropathy.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: hanan mohamed
- Telefonnummer: +962775661825
- E-Mail: h.hosny@zuj.edu.jo
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- age from 45 to 65 years old
- both Sex
- Have a documented diagnosis of diabetes mellitus for more than five years.
- Have clinically confirmed diabetic peripheral neuropathy affecting both the upper and lower limbs.
- Are medically stable and able to participate in the proposed rehabilitation program.
- Are able to understand the instructions and complete the required sensory and functional assessments.
- Provide written informed consent.
Exclusion Criteria
- Active foot ulcers, open wounds, or skin lesions that will make sensory testing or training unsafe.
- An acute foot infection or another condition requiring urgent medical management.
- Severe cognitive or visual impairment that will prevent safe participation in the proposed tasks.
- Another neurological or musculoskeletal condition that will substantially interfere with sensory assessment or the planned functional tasks.
- A medical condition that will make participation in the rehabilitation program unsafe.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Adaptive Gamified Sensory Training Group
The therapist will additionally record tactile discrimination accuracy, selected games, application settings, and progression between task levels. |
Participants will receive a 6-week intervention consisting of three sessions per week (18 sessions total), with each session lasting 90 minutes. The intervention will include 30 minutes of conventional physical therapy, 30 minutes of upper-limb sensory training involving tactile sensory discrimination and interactive gamified hand exercises using a Bluetooth-connected ball, and 30 minutes of lower-limb sensory training involving progressive, task-oriented activities using visual targets, safe textured surfaces, texture matching, and controlled foot placement and weight shifting. Task difficulty will be progressively adjusted according to participants' performance and tolerance. Device and tools: Bluetooth-connected interactive squeeze ball Foam balance pad Textured sensory stimulation materials Visual floor targets |
|
Aktiver Komparator: Conventional Physical Therapy Group
upper-limb conventional exercises Lower-limb strengthening: Conventional balance exercises: Gait and functional mobility training: |
Participants will receive a 6-week conventional rehabilitation program consisting of three sessions per week (18 sessions total), with each session lasting 90 minutes. The program will include 30 minutes of shared conventional physical therapy, 15 minutes of upper-limb range-of-motion and functional exercises, 15 minutes of lower-limb strengthening exercises, 15 minutes of balance training, and 15 minutes of gait and functional mobility training. Exercises will be adapted to participants' functional abilities and safety requirements. devices and tools: Foam balance pad Textured sensory stimulation materials Visual floor targets |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Neuropathy Impairment Scale (NIS) - Sensory Subset
Zeitfenster: 6 weeks
|
Change in sensory function from baseline to 6 weeks, assessed using the sensory subset of the Neuropathy Impairment Scale (NIS). Assessment includes touch pressure, pinprick, vibration, and joint position at the right and left index fingers and great toes. Higher scores indicate greater sensory impairment. Grading: NIS Sensory Subset
|
6 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Jebsen-Taylor Hand Function Test (JTHFT)
Zeitfenster: 6 weeks
|
Change in hand functional performance from baseline to post-intervention at 6 weeks, assessed using the Jebsen-Taylor Hand Function Test. Grading: Performance time in seconds for each subtest. Shorter completion times indicate better hand function.
Important: The JTHFT consists of seven timed subtests. Report the completion time in seconds for each subtest rather than treating it as a conventional 0-100 scale. |
6 weeks
|
|
Biodex Balance System-Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), if this is the specific test selected for your protocol. Device Biodex Balance System
Zeitfenster: 6 weeks
|
Condition 1: Eyes Open on a Firm Surface The participant stands on a firm, stable surface with eyes open. Visual, somatosensory, and vestibular information are available. Condition 2: Eyes Closed on a Firm Surface The participant stands on a firm, stable surface with eyes closed. Visual input is removed, increasing reliance on somatosensory and vestibular information. Condition 3: Eyes Open on a Foam Surface The participant stands on a foam surface with eyes open. The foam reduces the reliability of somatosensory information from the feet and ankles. Condition 4: Eyes Closed on a Foam Surface The participant stands on a foam surface with eyes closed. Both visual input and reliable somatosensory information are reduced, increasing reliance on vestibular information. Lower sway values generally indicate less postural sway and better postural stability. Higher sway values: generally indicate greater postural sway and poorer postural stability. |
6 weeks
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- Diabetic peripheral neuropathy
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .