Diabetic NeuropathiesNCT02790931
Effects of Foot Muscle Strengthening in Daily Activity in Diabetic Neuropathic Patients
A study testing Intervention Group in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus type 1 or 2
- Moderate or severe polyneuropathy confirmed with the fuzzy software
- Ability to walk independently in the laboratory
- Accessibility to electronic devices
- Loss of at least 4 degrees of ankle range of motion
- Loss of at least 1 degree of force in the clinical scale of the plantar interosseous or lumbrical muscles
Who cannot join
- Ulceration not healed for at least 6 months
- Hallux amputation or total amputation of the foot
- Receiving any physiotherapy intervention or offloading devices
- Neurological or orthopedic impairments
- Major vascular complications
- Severe retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
Read the detailed description
A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)
The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.
- Conditions
- Diabetic Neuropathies
- Being tested
- Intervention Group
- Keywords
- diabetic foot, therapeutic exercises, foot, preventive care, rehabilitation, Diabetic Neuropathy
- Medical subject headings
- Diabetic Neuropathies, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called Foot and ankle kinesiotherapy
Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. Receives: Other: Intervention Group |
| Control Group | No intervention | Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Physical Activity
Calculate the number of steps per week
Measured: 12 weeks
Self Selected Gait Speed
self selected gait speed shod walking velocity in a walkway
Measured: 12 weeks
Fast Gait Speed
Fast gait speed shod walking velocity in a walkway
Measured: 12 weeks
Secondary outcomes (11)
Risk Classification of Plantar Ulceration
Score of the classification of the plantar ulcer risk (IWG diabetic foot)
Measured: 12 weeks
Foot Health and Functionality
Score of the Foot Health Status questionnaire - BRAZIL
Measured: 12 weeks
Foot Strength
Hallux and lesser toes force measured by a pressure plate
Measured: 12 weeks
Foot and Ankle Kinematics During Gait
Foot joints and plantar arch motion, ankle range of motion, and maximum ankle extension and flexion during gait
Measured: baseline, 12 weeks
Ankle and Knee Joint Moments and Power During Gait
Peak joint moment and eccentric and concentric power by inverse dynamic calculations
Measured: baseline, 12 weeks
Plantar Ulcers
New cases of foot plantar ulcers
Measured: 12 months
Tactile Sensitivity
Evaluation of the tactile sensitivity of four plantar areas with 10g monofilament
Measured: 12 weeks
Vibration Sensitivity
Evaluation of the vibration sensitivity with tuning fork
Measured: 12 weeks
Neuropathy Symptoms
Score of the Michigan Neuropathy Screening Instrument questionnaire Michigan Neuropathy Screening Instrument (MNSI)
Measured: 12 weeks
Range of Motion
Manual goniometry of the range of motion of flexion and extension of the metatarsophalangeal joint of the hallux and ankle.
Measured: 12 weeks
EQ-5D Score
EQ-5D score of the quality of life of the patient
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)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 University of Sao Paulo General HospitalThe 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel de Camargo Neves Sacco, University of Sao Paulo General Hospital
- Investigators
- Isabel CN Sacco, PhD, Principal investigator, Associate Professor at São Paulo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790931
- Sponsor's protocol ID
- LaBiMPH
- Status last verified
- Dec 2024
- First submitted
- 25 May 2016
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0.
PubMed 35534614Monteiro 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Foot Muscle Strengthening in Daily Activity, Biomechanics and Functionality of Foot and Ankle in Diabetic Polyneuropathy Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02790931
- Acronym / sponsor ID
- LaBiMPH
- Conditions
- Diabetic Neuropathies
- Keywords
- diabetic foot, therapeutic exercises, foot, preventive care, rehabilitation, Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Posted 4 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this trial is to investigate the effects of foot muscle strengthening in daily activity of patients with diabetic neuropathy.
Detailed description
A randomized controlled trial will be performed with 77 patients with diabetic neuropathy. The participants will be randomly assigned into either a control group (recommended foot care by international consensus with no exercises) or an intervention group which will receive 12-week physical therapy exercises, twice a week, under the supervision of a physiotherapist, and twice a week being remotely supervised by a software at home. Every exercise has its own progression depending on the subjects' execution, increasing in intensity and difficulty.
The subjects will be evaluated in 5 different moments (Baseline, 6 weeks, 12 weeks, 24 weeks and 1 year follow-up)
The hypothesis of this study is that the intervention group will increase daily activity levels, increase self-selected and rapid walking speed, reduce the incidence of plantar ulcers, increase foot health and functionality, improve symptoms, increase tactile and vibration sensitivity, increased passive range of motion, improved quality of life, increased isometric strength of the feet and production of beneficial biomechanical changes during walking compared to the control group after 12 weeks of intervention and follow-up year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Intervention GroupPatients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months. |
| Control Group | No intervention | –Patients will not receive any exercise treatment, will not have acess to the software, but they will keep their recommended clinical treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus type 1 or 2
- Moderate or severe polyneuropathy confirmed with the fuzzy software
- Ability to walk independently in the laboratory
- Accessibility to electronic devices
- Loss of at least 4 degrees of ankle range of motion
Key exclusion criteria (6 listed)
- Ulceration not healed for at least 6 months
- Hallux amputation or total amputation of the foot
- Receiving any physiotherapy intervention or offloading devices
- Neurological or orthopedic impairments
- Major vascular complications
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 |
|---|---|---|
| Intervention GroupAlso: Foot and ankle kinesiotherapyPatients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year. | Other | Intervention Group |
Primary outcome
Daily Physical Activity
Time frame: 12 weeks
Calculate the number of steps per week
Self Selected Gait Speed
Time frame: 12 weeks
self selected gait speed shod walking velocity in a walkway
Fast Gait Speed
Time frame: 12 weeks
Fast gait speed shod walking velocity in a walkway
11 secondary outcomes
Risk Classification of Plantar Ulceration
Time frame: 12 weeks
Foot Health and Functionality
Time frame: 12 weeks
Foot Strength
Time frame: 12 weeks
Foot and Ankle Kinematics During Gait
Time frame: baseline, 12 weeks
Ankle and Knee Joint Moments and Power During Gait
Time frame: baseline, 12 weeks
Plantar Ulcers
Time frame: 12 months
Tactile Sensitivity
Time frame: 12 weeks
Vibration Sensitivity
Time frame: 12 weeks
Neuropathy Symptoms
Time frame: 12 weeks
Range of Motion
Time frame: 12 weeks
EQ-5D Score
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35534614Monteiro RL, Ferreira JSSP, Silva EQ, Cruvinel-Junior RH, Verissimo JL, Bus SA, Sacco ICN. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: a randomized controlled trial. Sci Rep. 2022 May 9;12(1):7561. doi: 10.1038/s41598-022-11745-0.
- Derived from this study: PubMed 30428863Monteiro 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.
- Laboratory of Biomechanics of Human Movement and Posture websiteLink provided by the sponsor.
- University of Sao Paulo websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Isabel CN Sacco, PhD principal investigator
Associate Professor at São Paulo 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 Intervention Group in people with Diabetic Neuropathies, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 27 Dec 2024. 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 Brazil. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daily Physical Activity (time frame: 12 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 NCT02790931, which also lists 2 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 27 Dec 2024.