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Diabetic Peripheral NeuropathyNCT04543032

Sensorimotor Training and Gait in Diabetic Polyneuropathy

A study testing sensorimotor training in people with Diabetic Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. It leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. Read more about this study

Who is it for?
Ages 50 to 65 years
Conditions the study is for
Diabetic Peripheral Neuropathy
What is being tested?
sensorimotor training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteEgypt
Study dates
5 Jan 2021to 7 Mar 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 50 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patient who have body mass index did not exceed 30 Kg/m2.
  • type II diabetes mellitus diagnosed for at least 7 years.
  • able to walk without assistance or assistive device
  • able to stand on both feet and on one leg
  • have controlled blood glucose level by the screening by Glycated Haemoglobin test (9 % > HbA1c > 6.5 %) .

Who cannot join

  • The patients will be excluded if they have:
  • cognitive deficits, severe retinopathy, scares under their feet, hypo or hypertension, any medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, other neurological or orthopaedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis), and severe nephropathy that causes edema or needs haemodialysis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Physical Therapy, Cairo University

    Giza, 12613

Other trials in Egypt

About this study

Official title: Effect of Sensorimotor Training on Gait, Ankle Muscle Strength and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. It leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. These alternations in gait performance cause increase in the risk of fall, which has the strongest association with symptoms of depression in patients with diabetes. However, little is known about possible treatment strategies for improving gait ability and reduce risk of fall in patients with diabetic neuropathy. So, the purpose of this study will be to investigate the effect of sensorimotor training on ankle muscle strength, gait and quality of life in patients with diabetic peripheral neuropathy.

To determine if there is an effect for sensorimotor training on gait, ankle muscle strength and quality of life in patients with diabetic peripheral neuropathy, the patient will be assessed before and after 6 weeks of treatment by measurement of ankle muscles strength using isokinetic dynamometer, measurement of different spatiotemporal gait parameters using gait trainer instrument , and assessment of quality of life of the patients using HRQL questionnaire (SF-36) before and after the treatment sessions.

Being tested
sensorimotor training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sensorimotor trainingOther

    Sensorimotor exercises progressed from stable surfaces to unstable surfaces, training gait in a line (tandem walk or walking straight) followed by gait including change in directions, gait without obstacles to gait with obstacles, change in the support base (feet apart and then together), physical exercises with eyes opened and closed, always respecting the functional capacity of each patient and progressively increasing the difficulty of each exercise. To help the training, cones, balance board, bars, mats and a mini-trampoline will be used. According to the patient progress, the exercises will be combined, generating circuits

Study groups in NCT04543032
Study groupRoleWhat they receive
study groupExperimentalthe patients in this group will receive sensorimotor training for 6 weeks in addition to medical care.
Receives: Other: sensorimotor training
control groupNo interventionthe patients in this group will receive medical care only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measurement of walking speed

    Speed of walking is one of time variables for measurement of kinematic gait analysis. It measured by (meter/second).

    It will be measured using the Biodex Gait Trainer: It is a device designed specifically for assessment, rehabilitation and retraining of gait for all patients, which composed of a treadmill with an instrumented deck that monitors and records kinematic gait parameters with a high resolution color touch screen (Liquid-Crystal Display) attached to the treadmill to control the device settings and display results.

    Measured: change from baseline at six weeks

  2. Measurement of step length

    Step length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the opposite foot and measured by (meter)

    It will be measured using the Biodex Gait Trainer

    Measured: change from baseline at six weeks

  3. Measurement of stride length

    Stride length is one of distance variables for measurement of kinematic gait analysis. It is the linear distance from the posterior aspect of the heel of one foot to the posterior aspect of the heel of the same foot and measured by (meter)

    It will be measured using the Biodex Gait Trainer

    Measured: change from baseline at six weeks

Secondary outcomes (3)

  1. Proprioception of ankle joint

    proprioception of ankle joint will be measured by Biodex Isokinetic dynamometer system (Biodex Medical Incorporated., Shirley, New York, USA).

    Measured: change from baseline at six weeks

  2. Muscle strength of ankle dorsiflexors and plantar flexors

    The strength of the dorsiflexors and plantar flexors muscles of the ankle will be measured by Biodex Isokinetic dynamometer system (Biodex Medical Incorporated., Shirley, New York, USA).

    Measured: change from baseline at six weeks

  3. Assessment of Quality of life

    Quality of life will be measured by the Short-Form Health Survey (SF-36) questionnaire.

    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale.

    The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    The eight sections are:

    • vitality
    • physical functioning
    • bodily pain
    • general health perceptions
    • physical role functioning
    • emotional role functioning
    • social role functioning
    • mental health

    Measured: change from baseline at six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start5 Jan 2021
  3. Primary completion20 May 2021
  4. Study completion7 Mar 2022

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543032
Sponsor's protocol ID
SMT for polyneuropathy
Status last verified
Oct 2022
First submitted
31 Aug 2020
Last updated
12 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mkandla K, Myezwa H, Musenge E. The effects of progressive-resisted exercises on muscle strength and health-related quality of life in persons with HIV-related poly-neuropathy in Zimbabwe. AIDS Care. 2016;28(5):639-43. doi: 10.1080/09540121.2015.1125418. Epub 2016 Jan 5.

    PubMed 26729347

  • Monteiro RL, Sartor CD, Ferreira JSSP, Dantas MGB, Bus SA, Sacco ICN. Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2018 Nov 14;19(1):400. doi: 10.1186/s12891-018-2323-0.

    PubMed 30428863

  • Mizukami H. [Pathophysiology of diabetic polyneuropathy]. Nihon Rinsho. 2016 Apr;74 Suppl 2:229-33. No abstract available. Japanese.

    PubMed 27266093

  • Saleh MSM, Elbanna RHM, Abdelhakiem NM, Abdalla GAE. Sensorimotor Training Improves Gait, Ankle Joint Proprioception, and Quality of Life in Patients With Diabetic Peripheral Neuropathy: A Single-Blinded Randomized Controlled Trial. Am J Phys Med Rehabil. 2024 Jul 1;103(7):638-644. doi: 10.1097/PHM.0000000000002453. Epub 2024 Feb 29.

    PubMed 38466203

Questions about this trial

What is this clinical trial studying?

A study testing sensorimotor training in people with Diabetic Peripheral Neuropathy, run by Cairo University at 1 site in Egypt.

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 5 inclusion and 2 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 12 Oct 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 Egypt. 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?

Measurement of walking speed (time frame: change from baseline at six weeks). The study lists 3 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 NCT04543032, which also lists 4 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 12 Oct 2022.

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