Diabetic Neuropathy With Loss of SensationPhase 1NCT01207284
Influence of Physical Therapy for Foot and Ankle in the Gait of Individuals With Diabetic Neuropathy
A Phase 1 study testing Physical Therapy in people with Diabetic Neuropathy With Loss of Sensation and Foot and Ankle Muscle Weakness, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Neuropathy With Loss of Sensation, Foot and Ankle Muscle Weakness, Foot and Ankle Range of Movement Restriction
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Jun 2013
- Phase
- Phase 1
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus type 1 or 2 diagnosed for at least seven years
- body mass index ranging 18.5-29.9 kg/m2 (normal and overweight classifications)
- diabetic polyneuropathy diagnosed by the medical care center: score higher than 2 out of 13 in the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, indicating the presence of at least two diabetic polyneuropathy symptoms; score higher than 1 out of 10 for physical assessment of the MNSI instrument, but always including impaired vibration perception
- ability to walk independently in the laboratory
Who cannot join
- ulceration not healed for at least 6 months
- partial or total foot amputation
- receiving any physiotherapy intervention or offloading devices
- neurological or orthopedic impairments
- major vascular complications
- severe retinopathy
- severe nephropathy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Speech, Physical Therapy and Occupational Therapy
São Paulo, São Paulo, 05360160
About this study
Official title: Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.
Read the detailed description
In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and 65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of lower limbs during gait.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
strengthening passive and active stretching balance training gait training
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy | Experimental | Foot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training. Receives: Other: Physical Therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak pressure at lateral forefoot
Measured: 12 weeks
Secondary outcomes (24)
Peak pressure
In 5 foot areas: heel, midfoot, medial forefoot, hallux and toes.
Measured: 12 weeks
Peak pressure
In foot areas: heel, midfoot, medial forefoot, lateral forefoot, hallux and toes.
Measured: 24 weeks
Time-to-peak pressure
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Measured: 12 weeks
Time-to-peak pressure
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Measured: 24 weeks
Pressure-time integral
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Measured: 12 weeks
Pressure-time integral
In 6 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux and toes.
Measured: 24 weeks
Mean velocity of center of pressure displacement
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Measured: 12 weeks
Mean velocity of center or pressure displacement
In 7 foot areas: heel, midfoot, lateral forefoot, medial forefoot, hallux, toes and total area.
Measured: 24 weeks
Sagittal range of motion of ankle
Measured: 12 weeks
Sagittal range of motion of ankle
Measured: 24 weeks
Sagittal peak of extensor moment of ankle
Measured: 12 weeks
Sagittal peak of extensor moment of ankle
Measured: 24 weeks
Sagittal peak of flexor moment of ankle
Measured: 12 weeks
Sagittal peak of flexor moment of ankle
Measured: 24 weeks
Michigan Neuropathy Screening Instrument score for symptoms
Measured: 12 weeks
Michigan Neuropathy Screening Instrument score for symptoms
Measured: 24 weeks
Michigan Neuropathy Screening Instrument score for physical assessment
Measured: 12 weeks
Michigan Neuropathy Screening Instrument score for physical assessment
Measured: 24 weeks
Functional tests score
Measured: 12 weeks
Functional tests score
Measured: 24 weeks
Muscle function score
Measured: 12 weeks
Muscle function score
Measured: 24 weeks
Activities-Specific Balance Confidence Scale (ABC)
Measured: 12 weeks
Activities-Specific Balance Confidence Scale (ABC)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy With Loss of SensationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Sponsor
- Investigators
- Isabel CN Sacco, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01207284
- Sponsor's protocol ID
- LaBiMPH-001
- Status last verified
- Sep 2013
- First submitted
- 20 Sep 2010
- Last updated
- 27 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
PubMed 24767584Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.
PubMed 22429765
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Therapy Intervention on the Foot and Ankle in Gait Biomechanics in Individuals With Diabetic Neuropathy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01207284
- Acronym / sponsor ID
- LaBiMPH-001
- Conditions
- Diabetic Neuropathy With Loss of Sensation, Foot and Ankle Muscle Weakness, Foot and Ankle Range of Movement Restriction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Aug 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Sep 2010 (estimated)
- 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.
The hypothesis is that a physical therapy intervention for foot and ankle of diabetic neuropathic individuals would affect positively the way they walk, lowering the harmful forces that these segments receive, that are associated mainly with lower range of movement, muscle weakness and loss of sensation. The participants will be randomly assigned into control group (regular treatment prescribed by their medical group) or into treatment group, that will receive 12 weeks of physical therapy intervention, twice a week, for 45 minutes each session. This will aim for increasing foot and ankle range of movement, muscle strength and improving sensory inputs.
Detailed description
In this study, were included subjects diagnosed with diabetic neuropathy, aged between 45 and 65 years old. We aimed to assess the effect of a physical therapy program on biomechanics of lower limbs during gait.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy | Experimental | Other: Physical TherapyFoot and ankle passive and active stretching, muscle strengthening, proprioception training and gait training. |
| Control | No intervention | – |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes mellitus type 1 or 2 diagnosed for at least seven years
- body mass index ranging 18.5-29.9 kg/m2 (normal and overweight classifications)
- diabetic polyneuropathy diagnosed by the medical care center: score higher than 2 out of 13 in the Michigan Neuropathy Screening Instrument (MNSI) questionnaire, indicating the presence of at least two diabetic polyneuropathy symptoms; score higher than 1 out of 10 for physical assessment of the MNSI instrument, but always including impaired vibration perception
- ability to walk independently in the laboratory
Key exclusion criteria (7 listed)
- ulceration not healed for at least 6 months
- partial or total foot amputation
- 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 |
|---|---|---|
| Physical Therapystrengthening passive and active stretching balance training gait training | Other | Physical Therapy |
Primary outcome
Peak pressure at lateral forefoot
Time frame: 12 weeks
24 secondary outcomes
Peak pressure
Time frame: 12 weeks
Peak pressure
Time frame: 24 weeks
Time-to-peak pressure
Time frame: 12 weeks
Time-to-peak pressure
Time frame: 24 weeks
Pressure-time integral
Time frame: 12 weeks
Pressure-time integral
Time frame: 24 weeks
Mean velocity of center of pressure displacement
Time frame: 12 weeks
Mean velocity of center or pressure displacement
Time frame: 24 weeks
Sagittal range of motion of ankle
Time frame: 12 weeks
Sagittal range of motion of ankle
Time frame: 24 weeks
Sagittal peak of extensor moment of ankle
Time frame: 12 weeks
Sagittal peak of extensor moment of ankle
Time frame: 24 weeks
Sagittal peak of flexor moment of ankle
Time frame: 12 weeks
Sagittal peak of flexor moment of ankle
Time frame: 24 weeks
Michigan Neuropathy Screening Instrument score for symptoms
Time frame: 12 weeks
Michigan Neuropathy Screening Instrument score for symptoms
Time frame: 24 weeks
Michigan Neuropathy Screening Instrument score for physical assessment
Time frame: 12 weeks
Michigan Neuropathy Screening Instrument score for physical assessment
Time frame: 24 weeks
Functional tests score
Time frame: 12 weeks
Functional tests score
Time frame: 24 weeks
Muscle function score
Time frame: 12 weeks
Muscle function score
Time frame: 24 weeks
Activities-Specific Balance Confidence Scale (ABC)
Time frame: 12 weeks
Activities-Specific Balance Confidence Scale (ABC)
Time frame: 24 weeks
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 27 Sep 2013.
- Derived from this study: PubMed 24767584Sartor CD, Hasue RH, Cacciari LP, Butugan MK, Watari R, Passaro AC, Giacomozzi C, Sacco IC. Effects of strengthening, stretching and functional training on foot function in patients with diabetic neuropathy: results of a randomized controlled trial. BMC Musculoskelet Disord. 2014 Apr 27;15:137. doi: 10.1186/1471-2474-15-137.
- Derived from this study: PubMed 22429765Sartor CD, Watari R, Passaro AC, Picon AP, Hasue RH, Sacco IC. Effects of a combined strengthening, stretching and functional training program versus usual-care on gait biomechanics and foot function for diabetic neuropathy: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Mar 19;13:36. doi: 10.1186/1471-2474-13-36.
Related trials for Diabetic Neuropathy With Loss of Sensation
RecruitingPhase 4
Benfotiamine Versus Vitamin B1-6-12 for 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.
Isabel CN Sacco study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical Therapy in people with Diabetic Neuropathy With Loss of Sensation and Foot and Ankle Muscle Weakness, 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 4 inclusion and 7 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 Sep 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Peak pressure at lateral forefoot (time frame: 12 weeks). 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 NCT01207284, 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 Sep 2013.