NCT07122726 Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients
| NCT ID | NCT07122726 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Foundation University Islamabad |
| Condition | Postural Balance |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2025-12-10 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-09-13 with a primary completion date of 2025-12-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Diabetes Mellitus is considered as one of the most prevalent issues among global population and 50% of all the diabetic patients particularly diabetes type II develop peripheral neuropathy. Diabetic Peripheral Neuropathy (DPN) affects feet and legs first, followed by the hands and arms. This study will involve two groups, one performing the Otago Exercise Program, and the other performing a combined PNF and Otago exercise protocol. This study aims to assess the additional effects of Proprioceptive Neuromuscular Facilitation with Otago Exercise Program on Risk of fall which will be assessed by assessing balance, Fear of Fall and Sensory Function. Key outcome measures, including the Berg Balance Scale, Fall Efficacy Scale, Functional Reach test and Semmes Weinstein Monofilament Test will be used in evaluating the effectiveness of the exercise interventions. The participants would be screened through Michigan Neuropathy Screening Instrument and Berg Balance scale for inclusion criteria, and outcome measures will be assessed by using Berg Balance Scale, Fall efficacy scale, Functional Reach Test and Semmes Weinstein Monofilament testing method on the day of starting the intervention and on the last day of intervention. Intervention will be given for a total of 40-50 minutes per session, 3 sessions/week for consecutive 6 weeks And than the data will be recorded at the end of 6 weeks again.
Eligibility Criteria
Inclusion Criteria: * Diabetes type 2 patients * 50-75 years of age * Both Males and Female Gender * Duration of diabetes more than 5 years * Participants positive for Michigan Neuropathy Screening Instrument * Patients having berg balance scale score \>20 Exclusion Criteria: * Surgical procedure involving knee, ankle, or hip joints. * Foot Ulcers and Deformities. * Diagnosis of neurological diseases (CVA, MS, Parkinson disease etc.) besides DPN. * Absence of Visual Impairment and Hearing loss Patients having comprehension difficulties * Physical disability that prevents from performing the exercises
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07122726 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 75 Years, studying Postural Balance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07122726 currently recruiting?
Yes, NCT07122726 is actively recruiting participants. Contact the research team at fatima.aziz425@gmail.com for enrollment information.
Where is the NCT07122726 trial being conducted?
This trial is being conducted at Islamabad, Pakistan.
Who is sponsoring the NCT07122726 clinical trial?
NCT07122726 is sponsored by Foundation University Islamabad. The trial plans to enroll 30 participants.