Postural BalanceNCT07122726
Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients
A study testing Otago and PNF exercise and Otago Exercise in people with Postural Balance and Fall Risk, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Postural Balance, Fall Risk, Diabetes (DM)
- What is being tested?
- Otago and PNF exercise and Otago Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Sep 2024to 10 Jan 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, 44000
Furqan Ahmed Siddiqi, Phd, 051-5788171 ext. 602, principal.fucp@fui.edu.pk
About this study
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.
Read the detailed description
The occurrence of diabetes mellitus (DM) is continually rising and has become one of the most evidently emerging chronic disease globally. One of the major consequence of Diabetes Mellitus is Diabetic Peripheral Neuropathy (DPN) which is associated with symptoms like pain, tingling, numbness, paresthesia, balance problems and falls etc. The overall pooled prevalence of diabetic peripheral neuropathy in Pakistan was estimated to be 43.16%. Diabetic Peripheral Neuropathy (DPN) causes weakness, numbness and pain in the hands and feet. Sensory disturbance leads to loss of vibration, pressure, temperature and pain. In addition people with DPN experience muscle weakness, loss of ankle reflexes, drop balance, loss of coordination etc.
Proprioceptive Neuromuscular Facilitation (PNF) is a system that uses diagonal and spiral movements, and different techniques like Reversal of Antagonists, Dynamic Reversals, and Rhythmic Initiation intended at facilitating, strengthening, gaining control of movement. The Otago Exercise Program was originally designed to prevent falls by improving balance. It involves leg muscle strengthening, walking and balance retraining exercises designed specifically to prevent falls and improve balance.
This study offers a novel approach by comparing the effects of the Otago Exercise Program with a combined PNF and Otago exercise protocol, targeting multiple domains crucial for functional improvement in DPN patients. This study is a randomized control trial and will be conducted for a duration of year, and Non-probability Convenient Sampling technique will be used for the study. The exercises will be performed for 6 weeks and thrice a week for 40-50 minutes on sample of 30 selected through G Power.
- Conditions
- Postural Balance, Fall Risk, Diabetes (DM), Fear of Falling, Sensory Function, Diabetic Neuropathy Peripheral
- Being tested
- Otago and PNF exercise, Otago Exercise
- Keywords
- Balance, Fall risk, Fear of fall, sensory function, Otago Exercises, Proprioceptive neuromuscular facilitation, Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago and PNF exerciseProcedure or surgery
Otago Exercise:
This 6-week protocol focuses on strengthening and balance exercises. It starts with supported exercises and progresses to unsupported ones. Exercises include knee flexors, extensors, and hip abductors with ankle weights, ankle plantar and dorsiflexors, knee bends, backward stepping, walking and turning, sideways walking, tandem stance, and one-leg stance. Repetitions increase over time, from 10-20 reps with support to 30 reps without support.
PNF Exercise The PNF protocol consists of 6 levels, progressing from simple to complex exercises. Level 1 involves D1/D2 patterns for ankle and hip with light resistance, while Level 2 focuses on seated D1/D2 patterns for the lower limb. Levels 3-6 introduce more dynamic exercises, including arm reaches while standing, PNF walking, dynamic step-ups, walking on unequal terrain, and obstacle navigation. The protocol emphasizes approximation, stabilization, resistance, and dynamic reversals to improve proprioception \& balance.
Otago ExerciseProcedure or surgery
Knee Flexors, Knee Extensors, Hip-abductors- 10 reps of each Exercise with ankle weights to provide muscle resistance. For ankle planter flexors and dorsi flexors starting from 20 repetitions at week 1 with hold support and ending at 30 repetitions without any support on 6th week. For knee bends starting with 10 reps at week 1 and ending at 30 reps without support at 6th week. Backward stepping 10 times 2 steps backward at week 1 progressing to 10 times x 4 Steps x No Support at week 6 gradually. Walking and Turning Around- (make a figure of 8), twice, first with support and then without support. Sideways Walking- 10 steps, 4 times x first with support and then without support over the time of 6 weeks. Tandem Stance- 10 seconds first with support and then without support. Tandem Walk/ 20 reps first with support and then without support over the period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Otago with PNF | Experimental | Otago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking The PNF pattern includes includes incorporating diagonal patterns, reversal of agonists, and combination of isotonic to enhance neuromuscular control. These techniques will be applied progressively based on patient response and capability. The gradually increasing resistance throughout the range of motion will be applied. The exercise intervention consists of 6 levels.
These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes. Receives: Procedure: Otago and PNF exercise |
| Otago Exercise | Active comparator | Otago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes. Receives: Procedure: Otago Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance will be assessed using berg balance scale. total score is 58. low fall risk is 0-20, moderate risk 20-40, High risk 41-58
Measured: 6 weeks
Fear of fall
The Falls Efficacy Scale-International (FES-I) will be used to measures the level of concern about falling. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned).
Measured: 6 weeks
Balance
The functional reach test will be performed to analyze dynamic balance. The patients will be instructed to position themselves with their body perpendicular to the wall but not touching the wall, with shoulders flexed at 90°, elbows extended, and hands closed. The assessor will record the starting position at the 3rd metacarpal head on the yardstick and then instruct the patient to reach as far as they can without taking a step, and the distance will be measured between the initial measurements to the final measurement.
Measured: 6 weeks
Sensory function
The SEMMES WEINSTEIN MONOFILAMNET TESTING is considered a simple and inexpensive touch threshold test and is widely used by clinicians to evaluate sensory disturbances of neuropathic diseases. With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.
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 posted14 Aug 2025
- Study start13 Sep 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122726
- Sponsor's protocol ID
- FUI/CTR/2024/83
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Proprioceptive Neuromuscular Facilitation With Otago Exercises on Fall Risk in Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT07122726
- Acronym / sponsor ID
- FUI/CTR/2024/83
- Conditions
- Postural Balance, Fall Risk, Diabetes (DM), Fear of Falling, Sensory Function, Diabetic Neuropathy Peripheral
- Keywords
- Balance, Fall risk, Fear of fall, sensory function, Otago Exercises, Proprioceptive neuromuscular facilitation, Diabetic Peripheral Neuropathy, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 14 Aug 2025 (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.
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.
Detailed description
The occurrence of diabetes mellitus (DM) is continually rising and has become one of the most evidently emerging chronic disease globally. One of the major consequence of Diabetes Mellitus is Diabetic Peripheral Neuropathy (DPN) which is associated with symptoms like pain, tingling, numbness, paresthesia, balance problems and falls etc. The overall pooled prevalence of diabetic peripheral neuropathy in Pakistan was estimated to be 43.16%. Diabetic Peripheral Neuropathy (DPN) causes weakness, numbness and pain in the hands and feet. Sensory disturbance leads to loss of vibration, pressure, temperature and pain. In addition people with DPN experience muscle weakness, loss of ankle reflexes, drop balance, loss of coordination etc.
Proprioceptive Neuromuscular Facilitation (PNF) is a system that uses diagonal and spiral movements, and different techniques like Reversal of Antagonists, Dynamic Reversals, and Rhythmic Initiation intended at facilitating, strengthening, gaining control of movement. The Otago Exercise Program was originally designed to prevent falls by improving balance. It involves leg muscle strengthening, walking and balance retraining exercises designed specifically to prevent falls and improve balance.
This study offers a novel approach by comparing the effects of the Otago Exercise Program with a combined PNF and Otago exercise protocol, targeting multiple domains crucial for functional improvement in DPN patients. This study is a randomized control trial and will be conducted for a duration of year, and Non-probability Convenient Sampling technique will be used for the study. The exercises will be performed for 6 weeks and thrice a week for 40-50 minutes on sample of 30 selected through G Power.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago with PNF | Experimental | Procedure: Otago and PNF exerciseOtago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking The PNF pattern includes includes incorporating diagonal patterns, reversal of agonists, and combination of isotonic to enhance neuromuscular control. These techniques will be applied progressively based on patient response and capability. The gradually increasing resistance throughout the range of motion will be applied. The exercise intervention consists of 6 levels. These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes. |
| Otago Exercise | Active comparator | Procedure: Otago ExerciseOtago exercise plan is comprised set of 14 exercises including strengthening and balance exercises. The strengthening exercises include strengthening of Knee Flexors, Knee Extensors, Hip-abductors Ankle dorsiflexors and ankle planter flexors and the balance exercises include following activities: Knee Bends Backward Walking, Walking and Turning Around, Sideways Walking, Tandem Stance, Tandem Walk, One Leg stance, Heel Walking, Toe Walking, Heel toe walk backwards, Sit to stand, Stair Walking These exercises will be performed for a duration 6 weeks and will be performed thrice for a period of 40/50 minutes. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Otago and PNF exerciseOtago Exercise: This 6-week protocol focuses on strengthening and balance exercises. It starts with supported exercises and progresses to unsupported ones. Exercises include knee flexors, extensors, and hip abductors with ankle weights, ankle plantar and dorsiflexors, knee bends, backward stepping, walking and turning, sideways walking, tandem stance, and one-leg stance. Repetitions increase over time, from 10-20 reps with support to 30 reps without support. PNF Exercise The PNF protocol consists of 6 levels, progressing from simple to complex exercises. Level 1 involves D1/D2 patterns for ankle and hip with light resistance, while Level 2 focuses on seated D1/D2 patterns for the lower limb. Levels 3-6 introduce more dynamic exercises, including arm reaches while standing, PNF walking, dynamic step-ups, walking on unequal terrain, and obstacle navigation. The protocol emphasizes approximation, stabilization, resistance, and dynamic reversals to improve proprioception \& balance. | Procedure or surgery | Otago with PNF |
| Otago ExerciseKnee Flexors, Knee Extensors, Hip-abductors- 10 reps of each Exercise with ankle weights to provide muscle resistance. For ankle planter flexors and dorsi flexors starting from 20 repetitions at week 1 with hold support and ending at 30 repetitions without any support on 6th week. For knee bends starting with 10 reps at week 1 and ending at 30 reps without support at 6th week. Backward stepping 10 times 2 steps backward at week 1 progressing to 10 times x 4 Steps x No Support at week 6 gradually. Walking and Turning Around- (make a figure of 8), twice, first with support and then without support. Sideways Walking- 10 steps, 4 times x first with support and then without support over the time of 6 weeks. Tandem Stance- 10 seconds first with support and then without support. Tandem Walk/ 20 reps first with support and then without support over the period of 6 weeks. | Procedure or surgery | Otago Exercise |
Primary outcome
Balance
Time frame: 6 weeks
Balance will be assessed using berg balance scale. total score is 58. low fall risk is 0-20, moderate risk 20-40, High risk 41-58
Fear of fall
Time frame: 6 weeks
The Falls Efficacy Scale-International (FES-I) will be used to measures the level of concern about falling. The level of concern is measured on a four point Likert scale (1=not at all concerned to 4=very concerned).
Balance
Time frame: 6 weeks
The functional reach test will be performed to analyze dynamic balance. The patients will be instructed to position themselves with their body perpendicular to the wall but not touching the wall, with shoulders flexed at 90°, elbows extended, and hands closed. The assessor will record the starting position at the 3rd metacarpal head on the yardstick and then instruct the patient to reach as far as they can without taking a step, and the distance will be measured between the initial measurements to the final measurement.
Sensory function
Time frame: 6 weeks
The SEMMES WEINSTEIN MONOFILAMNET TESTING is considered a simple and inexpensive touch threshold test and is widely used by clinicians to evaluate sensory disturbances of neuropathic diseases. With the patient's eyes closed, monofilament is applied perpendicularly in a steady manner until the filament bends. Use a smooth motion to touch the skin with the filament, bend the filament for a full second, than lift from the skin. Patient raises hand to indicate that the monofilament touch sensation is perceived.
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 14 Aug 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago and PNF exercise and Otago Exercise in people with Postural Balance and Fall Risk, run by Foundation University Islamabad at 1 site in Pakistan.
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 6 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: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Fatima Aziz, DPT (+92 3325920425, fatima.aziz425@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 14 Aug 2025.