| Registry | NCT07841730 |
|---|
| Status | Not yet recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: single, treatment |
|---|
| Enrollment | 38 (Estimated) |
|---|
| Sponsor | University of Lahore (Other) |
|---|
| Conditions | Diabetic Foot |
|---|
| Interventions | Tibial Nerve Mobilization, Multisensory exercises (Behavioral) |
|---|
| Dates | start 2026-09-01 (estimated), primary completion 2027-05-01 (estimated), completion 2027-05-01 (estimated), first posted 2026-09-25, last updated 2026-09-25 |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Diabetic Foot All trials of Tibial Nerve Mobilization All trials of Multisensory exercises
-Summary
The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Tibial Nerve Mobilization | Experimental | Behavioral: Tibial Nerve Mobilization | |
| Multisensory Exercises | Active comparator | Behavioral: Multisensory exercises | |
- Tibial Nerve Mobilization (Behavioral), also known as Nerve flossing, Neural Mobilization, Neural Gliding: Participants will receive supervised physical therapy targeting neuropathic symptoms, healing , mobility issues, quality of life associated with diabetic foot ulcers early grades. The regimen consists of 35 to 45 -minute sessions, 3 days per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy, including Transcutaneous Electrical Nerve Stimulation (TENS).Pulse Duration: 150 µs and 80 Hz frequency for effective nerve stimulation and pain relief, active and passive ankle range-of-motion exercises, dosriflexion and plantar flexion, inversion eversion ,with 10 repetitions for10 minutes and foot care education which includes moisturizing and hygiene advice and foot wear guidance . This is followed by a 20-minute main intervention of tibial nerve mobilization, which utilizes a combination of remote sliders, local sliders, and tensioners (end-range neural loading) to promote neural sliding and elongation while minimizing mechanical stress.
- Multisensory exercises (Behavioral): Participants will receive a multisensory exercises training program alongside conventional physical therapy. The regimen consists of 35-to 45 minute sessions, 3 times per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy (TENS, ankle range of motion, and foot care). Exercises include a structured warm-up, ankle flexion ,extension, inversion , eversion , short walk ,calf and hamstring stretching 10 repetitions Followed by 20 minutes of multisensory training.Visual system activities (e.g., eye tracking ,follow moving object , circular eye movements and visual-motor coordination. Somatosensory exercises (walking on varying surfaces such as flat surface , mattresses and foam rubber). Proprioception/vestibular stimulation (e.g., unipedal stances, tandem stance , tandem walking( heel to toe walk), walking variations such as backward , forward, multidirectional walking, and cognitive dual-task obstacle navigation eg. functional mobility training .
+Outcome measures
Primary outcomes
- Berg Balance Scale (BBS) [Baseline and immediately after 4 weeks of intervention]: The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.
Secondary outcomes
- Short Form-12 Health Survey (SF-12) [Baseline and immediately after 4 weeks of intervention]: Quality of Life SF12 Questionnaire :
The SF12 questionnaire used to assess the quality of life. It is a health related quality of life questionnaire including 12 questions.It has eight main which are some up into see physical and mental health. It has a scoring range from 0 to hundred for both physical as well as mental health.
- SINBAD Scoring System: [Baseline and immediately after 4 weeks of intervention]: Foot condition severity will be assessed using the SINBAD classification system, which evaluates site, ischemia, bacterial infection, area, and depth.
The SINBAD classification system will be used to assess the clinical status and severity of diabetic foot ulcer.
- Toronto Clinical Neuropathy Score (TCNS) [Baseline and immediately after 4 weeks of intervention]: It is used to assess the severity of the diabetic foot neuropathy. It assess the sensory test, reflexes as well as symptoms. It scoring shows from 0 to 5 shows no diabetic peripheral neuropathy, 6 to 8 shows mild diabetic peripheral neuropathy, 9 to 11 shows moderate diabetic peripheral neuropathy and 12 to 19 shows severe diabetic peripheral neuropathy. It has a good reliability of 0.83 to 0.87. It also has a good validity of 0.713.
+Eligibility
Sex: All, ages: 55 Years to 75 Years
Inclusion Criteria:
* Adults aged 55-75 years
* Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
* Both male and female participants.
* Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
* Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
* Patient with healed ulcer or in last stage of healing duration >1 to 2 weeks
* Absence of active infection.
* No cognitive impairments that would affect participation.
* Diabetes duration of less than 10 years.
* Able to perform the exercises and participate in physical therapy sessions.
* No history of amputation above the metatarsophalangeal joint.
Exclusion Criteria:
* Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
* Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
* Recent fractures, or trauma leading to nerve injuries in the last year.
* Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
* Visual impairments or cognitive disorders that could affect participation.
* History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
* Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
* Pregnancy or unwillingness to participate.
+Publications
- Yang L, Rong GC, Wu QN. Diabetic foot ulcer: Challenges and future. World J Diabetes. 2022 Dec 15;13(12):1014-1034. doi: 10.4239/wjd.v13.i12.1014. PMID 36578870
- Wang X, Yuan CX, Xu B, Yu Z. Diabetic foot ulcers: Classification, risk factors and management. World J Diabetes. 2022 Dec 15;13(12):1049-1065. doi: 10.4239/wjd.v13.i12.1049. PMID 36578871
- Waghe VR, Athawale V. Physiotherapeutic Interventions in Diabetic Foot Ulcer Management: A Case Report. Cureus. 2024 Feb 29;16(2):e55244. doi: 10.7759/cureus.55244. eCollection 2024 Feb. PMID 38558580
- Tran MM, Haley MN. Does exercise improve healing of diabetic foot ulcers? A systematic review. J Foot Ankle Res. 2021 Mar 20;14(1):19. doi: 10.1186/s13047-021-00456-w. PMID 33743791
- Ramachandran V, Mohanasundaram T, Karunakaran D, Gunasekaran M, Tiwari R. Physiological and Pathophysiological Aspects of Diabetic Foot Ulcer and its Treatment Strategies. Curr Diabetes Rev. 2023;19(8):e031122210617. doi: 10.2174/1573399819666221103141715. PMID 36330634
- McDermott K, Fang M, Boulton AJM, Selvin E, Hicks CW. Etiology, Epidemiology, and Disparities in the Burden of Diabetic Foot Ulcers. Diabetes Care. 2023 Jan 1;46(1):209-221. doi: 10.2337/dci22-0043. PMID 36548709
- Liu X, Ren Q, Zhai Y, Kong Y, Chen D, Chang B. Risk Factors for Multidrug-Resistant Organisms Infection in Diabetic Foot Ulcer. Infect Drug Resist. 2022 Apr 7;15:1627-1635. doi: 10.2147/IDR.S359157. eCollection 2022. PMID 35418765
- Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6. PMID 40016658
- Idiaquez JF, Alcantara M, Bril V. Optimal cut-off value of the modified Toronto Clinical Neuropathy Score in the diagnosis of polyneuropathy. Eur J Neurol. 2023 Aug;30(8):2481-2487. doi: 10.1111/ene.15870. Epub 2023 May 30. PMID 37203998
- Gupta G, Maiya GA, Bhat SN, Hande HM. Effect of Multifactorial Balance Rehabilitation Program on Risk of Falls and Functional Fitness in Older Adults with Diabetic Peripheral Neuropathy. Curr Aging Sci. 2023;16(3):240-247. doi: 10.2174/1874609816666230306150844. PMID 37638589
- Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec. PMID 36404825
- Chatzinikolaou A, Tzikas S, Lavdaniti M. Assessment of Quality of Life in Patients With Cardiovascular Disease Using the SF-36, MacNew, and EQ-5D-5L Questionnaires. Cureus. 2021 Sep 14;13(9):e17982. doi: 10.7759/cureus.17982. eCollection 2021 Sep. PMID 34667665
- Brocklehurst JD. The Validity and Reliability of the SINBAD Classification System for Diabetic Foot Ulcers. Adv Skin Wound Care. 2023 Nov 1;36(11):1-5. doi: 10.1097/ASW.0000000000000050. PMID 37861669
- Aagaard TV, Moeini S, Skou ST, Madsen UR, Brorson S. Benefits and Harms of Exercise Therapy for Patients With Diabetic Foot Ulcers: A Systematic Review. Int J Low Extrem Wounds. 2022 Sep;21(3):219-233. doi: 10.1177/1534734620954066. Epub 2020 Sep 14. PMID 32924691
- Aitken E, Hiew J, Hamilton EJ, Manning L, Ritter JC, Raby E, Gittings PM. Exercise in adults admitted to hospital with diabetes-related foot ulcers: a pilot study of feasibility and safety. J Foot Ankle Res. 2023 Mar 28;16(1):18. doi: 10.1186/s13047-023-00616-0. PMID 36978157
- Akkus G, Sert M. Diabetic foot ulcers: A devastating complication of diabetes mellitus continues non-stop in spite of new medical treatment modalities. World J Diabetes. 2022 Dec 15;13(12):1106-1121. doi: 10.4239/wjd.v13.i12.1106. PMID 36578865
- Armstrong DG, Tan TW, Boulton AJM, Bus SA. Diabetic Foot Ulcers: A Review. JAMA. 2023 Jul 3;330(1):62-75. doi: 10.1001/jama.2023.10578. PMID 37395769
- Ashoori M, Hashemi SE, Pourahmadi M, Dadgoo M, Hosseini MS, Lotfi H, Ahmadi M. Adding tibial nerve neurodynamic techniques to a rehabilitative pain management strategy improved neuropathy severity and quality of life in patients with diabetic peripheral neuropathy: a randomized sham-controlled trial. BMC Complement Med Ther. 2025 Nov 24;25(1):429. doi: 10.1186/s12906-025-05168-3. PMID 41286909
- Azharuddin M, Parveen S, Noohu MM. Effects of Neural Mobilization in Diabetic Peripheral Neuropathy: A Scoping Review. J Chiropr Med. 2023 Dec;22(4):313-321. doi: 10.1016/j.jcm.2023.10.002. Epub 2023 Nov 18. PMID 38205228
- Alshimy, A. M., Ibrahim, S. M., Osama, L., & Metwally, H. M. (2023). Effect of neurodynamic mobilization techniques in patients with diabetic neuropathy. Human Movement, 24(3), 115-120.