Diabetic Peripheral NeuropathyNCT07907289
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
A study testing Adaptive Gamified Sensory Training and Conventional Physical Therapy Group in people with Diabetic Peripheral Neuropathy, run by Al-Zaytoonah University of Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Adaptive Gamified Sensory Training and Conventional Physical Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2026to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Adaptive Gamified Sensory Training, Conventional Physical Therapy Group
- Keywords
- diabetic peripheral neuropathy, sensory function, NIS Sensory Subset, Gamified Sensory Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive Gamified Sensory TrainingOther
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.
Conventional Physical Therapy GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Gamified Sensory Training Group | Experimental | The therapist will additionally record tactile discrimination accuracy, selected games, application settings, and progression between task levels. Receives: Other: Adaptive Gamified Sensory Training |
| Conventional Physical Therapy Group | Active comparator | upper-limb conventional exercises
Lower-limb strengthening:
Conventional balance exercises:
Gait and functional mobility training: Receives: Other: Conventional Physical Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 Total score: 0-32, if all 16 site-by-modality ratings are scored.
Measured: 6 weeks
Secondary outcomes (2)
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.
Measured: 6 weeks
Biodex Balance System-Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), if this is the specific test selected for your protocol.
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.
ower sway values: generally indicate less postural sway and better postural stability.
Higher sway values: generally indicate greater postural sway and poorer postural stability.
The exact score name, units, calculatio
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start15 Nov 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Hosny M Battesha, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907289
- Sponsor's protocol ID
- Diabetic peripheral neuropathy
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907289
- Acronym / sponsor ID
- Diabetic peripheral neuropathy
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- diabetic peripheral neuropathy, sensory function, NIS Sensory Subset, Gamified Sensory Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adaptive Gamified Sensory Training Group | Experimental | Other: Adaptive Gamified Sensory TrainingThe therapist will additionally record tactile discrimination accuracy, selected games, application settings, and progression between task levels. |
| Conventional Physical Therapy Group | Active comparator | Other: Conventional Physical Therapy Groupupper-limb conventional exercises Lower-limb strengthening: Conventional balance exercises: Gait and functional mobility training: |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive Gamified Sensory TrainingParticipants 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. | Other | Adaptive Gamified Sensory Training Group |
| Conventional Physical Therapy GroupParticipants 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. | Other | Conventional Physical Therapy Group |
Primary outcome
Neuropathy Impairment Scale (NIS) - Sensory Subset
Time frame: 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 * 0 = Normal sensation * 1 = Decreased sensation * 2 = Absent sensation Total score: 0-32, if all 16 site-by-modality ratings are scored.
2 secondary outcomes
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: 6 weeks
Biodex Balance System-Modified Clinical Test of Sensory Interaction on Balance (mCTSIB), if this is the specific test selected for your protocol.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive Gamified Sensory Training and Conventional Physical Therapy Group in people with Diabetic Peripheral Neuropathy, run by Al-Zaytoonah University of Jordan.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact hanan mohamed (+962775661825, h.hosny@zuj.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathy Impairment Scale (NIS) - Sensory Subset (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.