Diabetic NeuropathiesNCT05190198
Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy
A study testing Proprioceptive neuromuscular facilitation and conventional therapy in people with Diabetic Neuropathies, run by Riphah International University at 1 site in Pakistan.
Trial summary
Diabetes mellitus is a metabolic disease described by hyperglycemia, which results from deficiencies in insulin secretion, the action of insulin on the target tissue, both. Chronic hyperglycemia can lead to long-standing damage and failure of various organs, including the kidneys, heart, eyes, blood vessels, and… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Proprioceptive neuromuscular facilitation and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2022to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients having peripheral neuropathy previously diagnosed by physician / Modified Toronto Clinical Neuropathy Score 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy
- Type II diabetes mellitus
- Timed up and go test <20 sec
- Berg Balance score between 20-40
- Able to walk without assistance or assistive device
- controlled blood glucose level
Who cannot join
- Cognitive Deficits
- Severe retinopathy
- Severe nephropathy that causes edema or needs hemodialysis.
- Scars under their feet
- Other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis)
- Any medical conditions that would confound the assessment of neuropathy, such as malignancy, active/untreated thyroid disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy
Diabetes mellitus is a metabolic disease described by hyperglycemia, which results from deficiencies in insulin secretion, the action of insulin on the target tissue, both. Chronic hyperglycemia can lead to long-standing damage and failure of various organs, including the kidneys, heart, eyes, blood vessels, and nerves. Diabetes mellitus is one of the world's biggest public health problems, affecting about 415 million people worldwide among adults aged 20 to 79 years. Patients with type 2 diabetic neuropathy (DN) are at increased risk of falls. This increased risk is likely because of the well-documented balance problems attributed to neuropathy and sensory ataxia, which is the lack of precise proprioceptive feedback. Sources of instability in patients with type 2 DN include loss or reduction of peripheral sensory information in the feet, the inability of the central nervous system (CNS) to appropriately integrate the available postural control information, and the shift from an ankle-based method to a hip-based balance strategy. In addition, increased use of vestibular information and reliance on visual information alter the style of postural control in patients with diabetic neuropathy. Individuals with diabetic peripheral neuropathy (DPN) are 15 times more likely to experience falls compared to healthy subjects.
Read the detailed description
Proprioception can help with joint stability, postural control, and many other conscious sensations. The diabetes mellitus patients showed a decrease in the reflex responses to postural disturbance followed by a decrease in the speed of nerve conduction which leads to disturbance of the balance and increases the risk of falls.The hip and ankle joints play important roles in the control of balance.The major functions of the ankle joint are control of balance against postural disturbances, shock absorption during walking, and movement of the lower limbs. To provide these, it is necessary to maintain a sufficient range of motion of the ankle joint, muscle strength, and proprioceptive sense.
A study reported that both proprioception exercise training and backward walking training are effective in increasing the proprioception sensation of lower limbs. However, proprioception exercise training was better than backward walking training in improving the feeling of proprioception in the lower limbs of patients with diabetic neuropathy. a study was conducted to investigate the effectiveness of an ankle proprioceptive control program on the gait of patients with chronic stroke. The study results provide evidence to support the effectiveness of an ankle proprioceptive control program in improving gait ability of patients with chronic stroke. A study reported that the addition of ankle proprioceptive training to traditional physical therapy exercises could provide more improvement of gait ability and decrease the risk of falling in patients with diabetic neuropathy.
Proper evidence behind ankle proprioception training in the improvement of balance in diabetic neuropathy patients is sparse and is based on different clinical experiences and fewer studies with limited methodological design. Despite the strong relationship between ankle proprioception and gait ability which has been reported in the previous research studies, up till now, there is no study to assess to what extent ankle proprioceptive training can improve balance in patients with diabetic neuropathy. So, the current study will investigate the effects of ankle proprioceptive training in improving the balance in patients with diabetic neuropathy.
- Conditions
- Diabetic Neuropathies
- Being tested
- Proprioceptive neuromuscular facilitation, conventional therapy
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitationOther
- Weight shifting in each direction (anteriorly, posteriorly, and lateral side) combined with side-to-side head movements (5 times for each direction).
- One-legged stance with slight knee flexion of another leg for 15 seconds (5 times for each leg).
- One-legged stance with increasing knee flexion of the other leg for 15 seconds (5 times for each leg).
- Standing on a balance pad with shifting weight (anteriorly, posteriorly, and lateral side) 10 times in each direction.
- In standing position, moving the weight left and right maximally.
- In standing position, moving the weight forward and backward maximally.
- In standing position, moving both heels of feet up and down.
- In standing position, bending and stretching both knees by squatting as much as possible.
conventional therapyOther
(Dorsiflexion, planter flexion, eversion and inversion) 10 repetitions for each movement.
(A) Sit to stand (5 times). (B) Standing with shifting Weight anteriorly, posteriorly, and sideway (5 times for each direction). (C) Functional reach sideway and anterior for touching targets set by the therapist (5 times for each direction). (D) Standing on heels for 20 seconds (5 times). (E) Standing on toes for 20 seconds (5 times).
(A) Spot marching (2 min). (B) Walking over the heels, toes, lateral border of feet with the preferred speed (6 min). (C) Tandem walking in a straight line (2 min).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will receive ankle proprioceptive training.
Ankle proprioceptive training includes the following group of exercises:
1. Training on the floor for 10 minutes (1-8 weeks)
2. Training on balance pad for 10 minutes (1-4 weeks)
3. Training on rocked balance board for 10 minutes (5-8 week) Receives: Other: Proprioceptive neuromuscular facilitation |
| Conventional therapy group | Active comparator | The control group will receive Traditional physical therapy exercises.
1. Active range of motion exercises for ankle and subtalar joints for 5 minutes.
2. Functional balance training for 15 minutes involving
3. Gait training for 10 minutes. Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Efficiency Scale-International (FES-I)
Risk of falling is assessed with Fall Efficiency Scale- International (FES-I). This is a self-reported 16-item scale of perceived confidence to complete physical daily activities. It scored each item on a four-point scale (1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned and 4 = very concerned). The possible total score is 64 in the worst case and 16 in the best condition to do all tasks with no concern of falling.
Measured: week 8
Timed up and go test (TUG)
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke.
10s Completely independent With or without walking aid for ambulation and transfers
< 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone
> 30s Requires assistance dependent in most activities
Measured: week 8
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Measured: week 8
Modified Toronto Clinical Neuropathy Score (mTCNS)
It is a screening tool for diabetic peripheral neuropathy and correlates with the severity of diabetic neuropathy. The mTCNS comprises two sub-scores only: symptom score and sensory test score. The values of the symptoms score range between 0 and 18 points.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start15 Jan 2022
- Primary completion27 Jul 2022
- Study completion27 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Afridi, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190198
- Sponsor's protocol ID
- REC/00819 Anam
- Status last verified
- Sep 2022
- First submitted
- 29 Dec 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atre JJ, Ganvir SS. Effect of functional strength training versus proprioceptive neuromuscular facilitation on balance and gait in patients with diabetic neuropathy. Indian Journal of Physical Therapy and Research. 2020;2(1):47
Ahmad I, Hussain E, Singla D, Verma S, Ali K. Balance training in diabetic peripheral neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1002.
Dominguez-Muñoz FJ, Hernández-Mocholi MA, Manso LJ, Collado-Mateo D, Villafaina S, Adsuar JC, et al. Test-retest reliability of kinematic parameters of timed up and go in people with type 2 diabetes. Applied Sciences. 2019;9(21):4709.
Skamagas M, Breen TL, LeRoith D. Update on diabetes mellitus: prevention, treatment, and association with oral diseases. Oral Dis. 2008 Mar;14(2):105-14. doi: 10.1111/j.1601-0825.2007.01425.x.
PubMed 18302671Olokoba AB, Obateru OA, Olokoba LB. Type 2 diabetes mellitus: a review of current trends. Oman Med J. 2012 Jul;27(4):269-73. doi: 10.5001/omj.2012.68.
PubMed 23071876Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
PubMed 32175717Asiimwe D, Mauti GO, Kiconco R. Prevalence and risk factors associated with type 2 diabetes in elderly patients aged 45-80 years at Kanungu District. Journal of diabetes research. 2020;2020.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.
PubMed 24357215Saleh MS, Rehab NI. Effect of ankle proprioceptive training on gait and risk of fall in patients with diabetic neuropathy: A randomized controlled trial. International Journal of Diabetes Research. 2019;2(1):40-5.
Jeannin AC, Salem JE, Massy Z, Aubert CE, Vermeer C, Amouyal C, Phan F, Halbron M, Funck-Brentano C, Hartemann A, Bourron O. Inactive matrix gla protein plasma levels are associated with peripheral neuropathy in Type 2 diabetes. PLoS One. 2020 Feb 24;15(2):e0229145. doi: 10.1371/journal.pone.0229145. eCollection 2020.
PubMed 32092076
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05190198
- Acronym / sponsor ID
- REC/00819 Anam
- Conditions
- Diabetic Neuropathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 27 Jul 2022 (actual)
- Study completion
- 27 Jul 2022 (actual)
- First posted
- 13 Jan 2022 (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 a metabolic disease described by hyperglycemia, which results from deficiencies in insulin secretion, the action of insulin on the target tissue, both. Chronic hyperglycemia can lead to long-standing damage and failure of various organs, including the kidneys, heart, eyes, blood vessels, and nerves. Diabetes mellitus is one of the world's biggest public health problems, affecting about 415 million people worldwide among adults aged 20 to 79 years. Patients with type 2 diabetic neuropathy (DN) are at increased risk of falls. This increased risk is likely because of the well-documented balance problems attributed to neuropathy and sensory ataxia, which is the lack of precise proprioceptive feedback. Sources of instability in patients with type 2 DN include loss or reduction of peripheral sensory information in the feet, the inability of the central nervous system (CNS) to appropriately integrate the available postural control information, and the shift from an ankle-based method to a hip-based balance strategy. In addition, increased use of vestibular information and reliance on visual information alter the style of postural control in patients with diabetic neuropathy. Individuals with diabetic peripheral neuropathy (DPN) are 15 times more likely to experience falls compared to healthy subjects.
Detailed description
Proprioception can help with joint stability, postural control, and many other conscious sensations. The diabetes mellitus patients showed a decrease in the reflex responses to postural disturbance followed by a decrease in the speed of nerve conduction which leads to disturbance of the balance and increases the risk of falls.The hip and ankle joints play important roles in the control of balance.The major functions of the ankle joint are control of balance against postural disturbances, shock absorption during walking, and movement of the lower limbs. To provide these, it is necessary to maintain a sufficient range of motion of the ankle joint, muscle strength, and proprioceptive sense.
A study reported that both proprioception exercise training and backward walking training are effective in increasing the proprioception sensation of lower limbs. However, proprioception exercise training was better than backward walking training in improving the feeling of proprioception in the lower limbs of patients with diabetic neuropathy. a study was conducted to investigate the effectiveness of an ankle proprioceptive control program on the gait of patients with chronic stroke. The study results provide evidence to support the effectiveness of an ankle proprioceptive control program in improving gait ability of patients with chronic stroke. A study reported that the addition of ankle proprioceptive training to traditional physical therapy exercises could provide more improvement of gait ability and decrease the risk of falling in patients with diabetic neuropathy.
Proper evidence behind ankle proprioception training in the improvement of balance in diabetic neuropathy patients is sparse and is based on different clinical experiences and fewer studies with limited methodological design. Despite the strong relationship between ankle proprioception and gait ability which has been reported in the previous research studies, up till now, there is no study to assess to what extent ankle proprioceptive training can improve balance in patients with diabetic neuropathy. So, the current study will investigate the effects of ankle proprioceptive training in improving the balance in patients with diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Proprioceptive neuromuscular facilitationThe experimental group will receive ankle proprioceptive training. Ankle proprioceptive training includes the following group of exercises: 1. Training on the floor for 10 minutes (1-8 weeks) 2. Training on balance pad for 10 minutes (1-4 weeks) 3. Training on rocked balance board for 10 minutes (5-8 week) |
| Conventional therapy group | Active comparator | Other: conventional therapyThe control group will receive Traditional physical therapy exercises. 1. Active range of motion exercises for ankle and subtalar joints for 5 minutes. 2. Functional balance training for 15 minutes involving 3. Gait training for 10 minutes. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients having peripheral neuropathy previously diagnosed by physician / Modified Toronto Clinical Neuropathy Score 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy
- Type II diabetes mellitus
- Timed up and go test <20 sec
- Berg Balance score between 20-40
- Able to walk without assistance or assistive device
Key exclusion criteria (6 listed)
- Cognitive Deficits
- Severe retinopathy
- Severe nephropathy that causes edema or needs hemodialysis.
- Scars under their feet
- Other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis)
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitation* Weight shifting in each direction (anteriorly, posteriorly, and lateral side) combined with side-to-side head movements (5 times for each direction). * One-legged stance with slight knee flexion of another leg for 15 seconds (5 times for each leg). * One-legged stance with increasing knee flexion of the other leg for 15 seconds (5 times for each leg). * Standing on a balance pad with shifting weight (anteriorly, posteriorly, and lateral side) 10 times in each direction. * In standing position, moving the weight left and right maximally. * In standing position, moving the weight forward and backward maximally. * In standing position, moving both heels of feet up and down. * In standing position, bending and stretching both knees by squatting as much as possible. | Other | Experimental group |
| conventional therapy(Dorsiflexion, planter flexion, eversion and inversion) 10 repetitions for each movement. (A) Sit to stand (5 times). (B) Standing with shifting Weight anteriorly, posteriorly, and sideway (5 times for each direction). (C) Functional reach sideway and anterior for touching targets set by the therapist (5 times for each direction). (D) Standing on heels for 20 seconds (5 times). (E) Standing on toes for 20 seconds (5 times). (A) Spot marching (2 min). (B) Walking over the heels, toes, lateral border of feet with the preferred speed (6 min). (C) Tandem walking in a straight line (2 min). | Other | Conventional therapy group |
Primary outcome
Fall Efficiency Scale-International (FES-I)
Time frame: week 8
Risk of falling is assessed with Fall Efficiency Scale- International (FES-I). This is a self-reported 16-item scale of perceived confidence to complete physical daily activities. It scored each item on a four-point scale (1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned and 4 = very concerned). The possible total score is 64 in the worst case and 16 in the best condition to do all tasks with no concern of falling.
Timed up and go test (TUG)
Time frame: week 8
The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities
Berg Balance Scale
Time frame: week 8
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
Modified Toronto Clinical Neuropathy Score (mTCNS)
Time frame: week 8
It is a screening tool for diabetic peripheral neuropathy and correlates with the severity of diabetic neuropathy. The mTCNS comprises two sub-scores only: symptom score and sensory test score. The values of the symptoms score range between 0 and 18 points.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- BackgroundAtre JJ, Ganvir SS. Effect of functional strength training versus proprioceptive neuromuscular facilitation on balance and gait in patients with diabetic neuropathy. Indian Journal of Physical Therapy and Research. 2020;2(1):47
- BackgroundAhmad I, Hussain E, Singla D, Verma S, Ali K. Balance training in diabetic peripheral neuropathy: A Narrative Review. JSM Diabetol Manag. 2017;2(1):1002.
- BackgroundDominguez-Muñoz FJ, Hernández-Mocholi MA, Manso LJ, Collado-Mateo D, Villafaina S, Adsuar JC, et al. Test-retest reliability of kinematic parameters of timed up and go in people with type 2 diabetes. Applied Sciences. 2019;9(21):4709.
- Background: PubMed 18302671Skamagas M, Breen TL, LeRoith D. Update on diabetes mellitus: prevention, treatment, and association with oral diseases. Oral Dis. 2008 Mar;14(2):105-14. doi: 10.1111/j.1601-0825.2007.01425.x.
- Background: PubMed 23071876Olokoba AB, Obateru OA, Olokoba LB. Type 2 diabetes mellitus: a review of current trends. Oman Med J. 2012 Jul;27(4):269-73. doi: 10.5001/omj.2012.68.
- Background: PubMed 32175717Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.
- BackgroundAsiimwe D, Mauti GO, Kiconco R. Prevalence and risk factors associated with type 2 diabetes in elderly patients aged 45-80 years at Kanungu District. Journal of diabetes research. 2020;2020.
- Background: PubMed 24357215American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2014 Jan;37 Suppl 1:S81-90. doi: 10.2337/dc14-S081. No abstract available.
- BackgroundSaleh MS, Rehab NI. Effect of ankle proprioceptive training on gait and risk of fall in patients with diabetic neuropathy: A randomized controlled trial. International Journal of Diabetes Research. 2019;2(1):40-5.
- Background: PubMed 32092076Jeannin AC, Salem JE, Massy Z, Aubert CE, Vermeer C, Amouyal C, Phan F, Halbron M, Funck-Brentano C, Hartemann A, Bourron O. Inactive matrix gla protein plasma levels are associated with peripheral neuropathy in Type 2 diabetes. PLoS One. 2020 Feb 24;15(2):e0229145. doi: 10.1371/journal.pone.0229145. eCollection 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Neuropathies
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
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. This study is not recruiting at the moment.
Ayesha Afridi, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive neuromuscular facilitation and conventional therapy in people with Diabetic Neuropathies, run by Riphah International University 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 6 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: finished, as of the sponsor's last update on 21 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Efficiency Scale-International (FES-I) (time frame: week 8). 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?
On the ClinicalTrials.gov record for NCT05190198, which also lists 10 linked publications.
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 21 Sep 2022.