- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190198
Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy
Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kallar Kahar, Pakistan
- Maryam Day Care Clinic Kallar Kahar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Experimental group
The experimental group will receive ankle proprioceptive training. Ankle proprioceptive training includes the following group of exercises:
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Active Comparator: Conventional therapy group
The control group will receive Traditional physical therapy exercises.
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(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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fall Efficiency Scale-International (FES-I)
Time Frame: week 8
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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.
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week 8
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Timed up and go test (TUG)
Time Frame: week 8
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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 |
week 8
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Berg Balance Scale
Time Frame: week 8
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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.
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week 8
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Modified Toronto Clinical Neuropathy Score (mTCNS)
Time Frame: week 8
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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.
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week 8
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Khan 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.
- 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.
- 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.
- Olokoba 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.
- Asiimwe 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.
- Saleh 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. Erratum In: PLoS One. 2020 May 5;15(5):e0232996.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/00819 Anam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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