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Not yet recruitingNCT07907289Updated Nov 4, 2026

Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy

An interventional study of Adaptive Gamified Sensory Training and Conventional Physical Therapy Group in Diabetic Peripheral Neuropathy, sponsored by Al-Zaytoonah University of Jordan. Not yet recruiting. Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Al-Zaytoonah University of Jordan · Not applicable, Interventional, and Treatment

Updated Nov 4, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • diabetic peripheral neuropathy
  • sensory function
  • NIS Sensory Subset
  • Gamified Sensory Training
03

In context

Lead sponsor

Al-Zaytoonah University of Jordan is the lead sponsor of 31 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Adaptive Gamified Sensory Training Group

    The therapist will additionally record tactile discrimination accuracy, selected games, application settings, and progression between task levels.

    Other: Adaptive Gamified Sensory Training

  • Active comparator
    Conventional Physical Therapy Group

    upper-limb conventional exercises Lower-limb strengthening: Conventional balance exercises: Gait and functional mobility training:

    Other: Conventional Physical Therapy Group

Interventions

  • OtherAdaptive Gamified Sensory Training

    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

  • OtherConventional Physical Therapy Group

    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

06

What researchers measure

Primary outcomes

  1. Neuropathy Impairment Scale (NIS) - Sensory Subset

    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 * 0 = Normal sensation * 1 = Decreased sensation * 2 = Absent sensation Scale title: Neuropathy Impairment Scale - Sensory Subset (NIS Sensory Subset). Minimum value: 0 Maximum value: 32\* Interpretation: Higher scores indicate worse sensory impairment; lower scores indicate better sensory function.

    Time frame: 6 weeks

Secondary outcomes

  1. Jebsen-Taylor Hand Function Test (JTHFT)

    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. * Unabbreviated scale title: Jebsen-Taylor Hand Function Test. * Minimum value: 0 seconds (theoretical minimum). * Maximum value: No fixed maximum; the score is recorded as the time required to complete each task. * Interpretation: Higher scores (longer completion times) indicate worse hand function, whereas lower scores (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.

    Time frame: 6 weeks

  2. 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

    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.

    Time frame: 6 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2026, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 25, 2026
First posted
Oct 30, 2026
StartEst.
Nov 15, 2026
Primary completionEst.
Dec 15, 2026
CompletionEst.
Dec 25, 2026
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
1 description edited
What changed in the outcomes
  • DescriptionNeuropathy Impairment Scale (NIS) - Sensory Subset: how it is measured was reworded
Nov 4, 2026
Secondary outcomes
1 edited, 1 description edited
What changed in the outcomes
  • EditedBiodex Balance System-Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), if this is the specific test selected for your protocol. Device Biodex Balance SystemTime frame: 6 weeks
  • DescriptionJebsen-Taylor Hand Function Test (JTHFT): how it is measured was reworded
Nov 4, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 4, 2026
    Primary outcomes 1 description edited
    What changed in the outcomes
    • DescriptionNeuropathy Impairment Scale (NIS) - Sensory Subset: how it is measured was reworded
    Secondary outcomes 1 edited, 1 description edited
    What changed in the outcomes
    • EditedBiodex Balance System-Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), if this is the specific test selected for your protocol. Device Biodex Balance SystemTime frame: 6 weeks
    • DescriptionJebsen-Taylor Hand Function Test (JTHFT): how it is measured was reworded
    + 2 other changes: verification date and arm descriptions
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907289
Lead sponsor
Al-Zaytoonah University of Jordan
Responsible party
Hanan Hosny M Battesha (associate professor, Al-Zaytoonah University of Jordan) — Principal investigator
First posted
Oct 30, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Dec 15, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Nov 4, 2026

Study contacts

hanan mohamed
Contact
h.hosny@zuj.edu.jo
+962775661825

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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