Complications of Diabetes MellitusNCT01926522
Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients
A study testing Technological Rehabilitation in people with Complications of Diabetes Mellitus and Diabetic Neuropathies, run by Giovanni Taveggia at 1 site in Italy.
Trial summary
The investigators evaluated the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Complications of Diabetes Mellitus, Diabetic Neuropathies
- What is being tested?
- Technological Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Nov 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants need to have a history of diabetes mellitus type 2, >3 years, (i.e., time from the diagnosis or the beginning of first related signs or symptoms),
- A diagnosis of Distal Sensorimotor Polyneuropathy associated,
- Able to walk autonomously, eventually with a aid.
Who cannot join
- Scoring less than 5 points on the Functional Independence Measure (FIM) (7) locomotion scale,
- Presenting articular ankyloses, contractures, spasms with important locomotion effects,
- Presenting bony instability affecting lower limb functionality (unconsolidated fractures, vertebral instability, severe osteoporosis),
- In presence of attendant clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and different other conditions),
- In presence of cutaneous lesions at lower limbs,
- Scoring less than 22 points on the Mini Mental State Examination (MMSE),
- Exhibit important behavioural diseases involving aggressivity or psychotic disorders.
- Had received prior interventions for Distal Sensorimotor Polyneuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
The investigators evaluated the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
Read the detailed description
Recent studies witnessed how physical exercise may interrupt the devastating decrease of muscle performance in DSP and further experiments are underway to find more exercises for the recovery of motor function impairment. In fact the rehabilitation treatment, that aims at reducing motor disability, preserving gait functions and preventing falling risks, is an interesting therapeutic approach. Literature recommends balance re-training exercises, muscle strengthening, selective stretching and retraining of motor activity.
New technologies produced in the recent decades different devices used in strengthening exercises (electromechanical dynamometers), balance recovery (balance platforms) and gait (analyzing treadmills) have visual feedbacks through which the patients may independently monitor accuracy and intensity of their exercises, being therefore strongly motivated and resulting in a high training intensity. These technologies are often used in rehabilitation of different patients, but are rarely employed for DSP.
The purpose of this case control study was to examine the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
- Being tested
- Technological Rehabilitation, Control Rehabilitation
- Keywords
- Exercise Therapy
- Medical subject headings
- Diabetes Complications, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological RehabilitationDevice
Also called Dynamometric isokinetic device: Biodex System 4,, Balance device: Biodex Balance System SD,, Analyzing treadmill: Biodex Gait Trainer 3.
The length of stride of reference used during the exercise is personalized and depends on the height of patients. Each patient carries out the feedback for 20 minutes with the aim of generating the most symmetric and regular gait.
Patients, with the dynamometer, work on strengthening of flexor and extensor muscles with ankle speeds at 90°/sec and 120°/sec. The strengthening technique was performed twice for 10 minutes each time with a 1 minute rest between sets.
The session ends with a 20-minute feedback on dynamic balance platform by carrying out exercises in which they need to reach randomly appearing targets. Subjects begin with 12 minutes the first 4 sessions, progress to 16 minutes the next 2 sessions, then 18' (2 sessions), and finally 20', if able, during the last 4 sessions.
Control RehabilitationOther
Also called Manual rehabilitation with the therapist.
When needed, more than on e therapist are employed in the intervention for safety reasons.
| Study group | Role | What they receive |
|---|---|---|
| Technological Rehabilitation | Experimental | Experimental group receives a treatment of: 20 minutes of analyzing treadmill with feedback focused on symmetry and length of stride; 20 minutes of isokinetic dynamometric muscle strengthening of flexor and extensor muscles of tibiotarsal joint; 20 minutes of balance retraining on dynamic balance platform. Each patient receives 20 sessions over a period of 4 weeks (5 sessions per week). Receives: Device: Technological Rehabilitation |
| Control Rehabilitation | Active comparator | Control group receives the same number of treatment sessions of same duration as those in the experimental group: activities targeted to improve the endurance (instead of analyzing treadmill ), manual exercises of lower limb muscle strengthening, stretching exercises (instead of dynamometer), gait retraining on the floor for 20 minutes and static and dynamic balance exercises in upright position (instead of dynamic balance platform). Receives: Other: Control Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of 6-minute walk test
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance.
The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Measured: 1 day after the treatment
Change from Baseline of 10-metres walk test
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed.
The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Measured: 1 day after the treatment
Secondary outcomes (26)
Followup change from Baseline of 6-minute walk test
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance.
The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Measured: 30 days after the treatment
Followup change from Baseline of 10-metres walk test
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed.
The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Measured: 30 days after the treatment
Change from Baseline of the Functional Independence Measure (FIM)
Measured: 1 day after the treatment
Change from Baseline of the Tinetti scale
Measured: 1 day after the treatment
Change from Baseline of the Resting Energy Expenditure (REE)
Measured: 1 day after the treatment
Change from Baseline of the Respiratory Rate (RR)
Measured: 1 day after the treatment
Change from Baseline of the Heart Rate (HR)
Measured: 1 day after the treatment
Change from Baseline of the oxygen saturation (SpO2)
Measured: 1 day after the treatment
Change from Baseline of the maximal oxygen consumption (VO2 max)
Measured: 1 day after the treatment
Change from Baseline of the expired minute volume (Ve)
Measured: 1 day after the treatment
Change from Baseline of the fraction of expired air that is oxygen (FeO2)
Measured: 1 day after the treatment
Change from Baseline of the Systolic Blood Pressure (SBP)
Measured: 1 day after the treatment
Change from Baseline of the Diastolic Blood Pressure (DBP)
Measured: 1 day after the treatment
Change from Baseline of the Glycated Hemoglobin (HbA1c)
Measured: 1 day after the treatment
Followup change from Baseline of the Functional Independence Measure (FIM)
Measured: 30 days after the treatment
Followup change from Baseline of the Tinetti scale
Measured: 30 days after the treatment
Followup change from Baseline of the Resting Energy Expenditure (REE)
Measured: 30 days after the treatment
Followup change from Baseline of the Respiratory Rate (RR)
Measured: 30 days after the treatment
Followup change from Baseline of the Heart Rate (HR)
Measured: 30 days after the treatment
Followup change from Baseline of the oxygen saturation (SpO2)
Measured: 30 days after the treatment
Followup change from Baseline of the maximal oxygen consumption (VO2 max)
Measured: 30 days after the treatment
Followup change from Baseline of the expired minute volume (Ve)
Measured: 30 days after the treatment
Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
Measured: 30 days after the treatment
Followup change from Baseline of the Systolic Blood Pressure (SBP)
Measured: 30 days after the treatment
Followup change from Baseline of the Diastolic Blood Pressure (DBP)
Measured: 30 days after the treatment
Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
Measured: 30 days after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Complications of Diabetes MellitusStudies of the same condition, open and under way.
- 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Giovanni Taveggia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giovanni Taveggia, Habilita, Ospedale di Sarnico
- Investigators
- Giovanni Taveggia, MD, Principal investigator, Habilita, Ospedale di Sarnico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926522
- Sponsor's protocol ID
- Habilita-RAR-02
- Other IDs
- 201206180007491711110
- Status last verified
- Mar 2014
- First submitted
- 14 Aug 2013
- Last updated
- 24 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
PubMed 22271730Starling JR, Harms BA. Diagnosis and treatment of genitofemoral and ilioinguinal neuralgia. World J Surg. 1989 Sep-Oct;13(5):586-91. doi: 10.1007/BF01658875.
PubMed 2815802Ites KI, Anderson EJ, Cahill ML, Kearney JA, Post EC, Gilchrist LS. Balance interventions for diabetic peripheral neuropathy: a systematic review. J Geriatr Phys Ther. 2011 Jul-Sep;34(3):109-16. doi: 10.1519/JPT.0b013e318212659a.
PubMed 21937901Fedele D, Comi G, Coscelli C, Cucinotta D, Feldman EL, Ghirlanda G, Greene DA, Negrin P, Santeusanio F. A multicenter study on the prevalence of diabetic neuropathy in Italy. Italian Diabetic Neuropathy Committee. Diabetes Care. 1997 May;20(5):836-43. doi: 10.2337/diacare.20.5.836.
PubMed 9135952Aring AM, Jones DE, Falko JM. Evaluation and prevention of diabetic neuropathy. Am Fam Physician. 2005 Jun 1;71(11):2123-8.
PubMed 15952441Divisova S, Vlckova E, Hnojcikova M, Skorna M, Nemec M, Dubovy P, Dusek L, Jarkovsky J, Belobradkova J, Bednarik J. Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. J Peripher Nerv Syst. 2012 Sep;17(3):341-50. doi: 10.1111/j.1529-8027.2012.00420.x.
PubMed 22971096Spencer RJ, Wendell CR, Giggey PP, Katzel LI, Lefkowitz DM, Siegel EL, Waldstein SR. Psychometric limitations of the mini-mental state examination among nondemented older adults: an evaluation of neurocognitive and magnetic resonance imaging correlates. Exp Aging Res. 2013;39(4):382-97. doi: 10.1080/0361073X.2013.808109.
PubMed 23875837ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
PubMed 12091180Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
PubMed 22588756Nascimento LR, Caetano LC, Freitas DC, Morais TM, Polese JC, Teixeira-Salmela LF. Different instructions during the ten-meter walking test determined significant increases in maximum gait speed in individuals with chronic hemiparesis. Rev Bras Fisioter. 2012 Apr;16(2):122-7. doi: 10.1590/s1413-35552012005000008. Epub 2012 Mar 1. English, Portuguese.
PubMed 22378478Gomes AA, Onodera AN, Otuzi ME, Pripas D, Mezzarane RA, Sacco IC. Electromyography and kinematic changes of gait cycle at different cadences in diabetic neuropathic individuals. Muscle Nerve. 2011 Aug;44(2):258-68. doi: 10.1002/mus.22051.
PubMed 21755508van Sloten TT, Savelberg HH, Duimel-Peeters IG, Meijer K, Henry RM, Stehouwer CD, Schaper NC. Peripheral neuropathy, decreased muscle strength and obesity are strongly associated with walking in persons with type 2 diabetes without manifest mobility limitations. Diabetes Res Clin Pract. 2011 Jan;91(1):32-9. doi: 10.1016/j.diabres.2010.09.030. Epub 2010 Oct 20.
PubMed 20965601Thomas T, Schreiber G. Acute-phase response of plasma protein synthesis during experimental inflammation in neonatal rats. Inflammation. 1985 Mar;9(1):1-7. doi: 10.1007/BF00915406.
PubMed 2579907Corriveau H, Prince F, Hebert R, Raiche M, Tessier D, Maheux P, Ardilouze JL. Evaluation of postural stability in elderly with diabetic neuropathy. Diabetes Care. 2000 Aug;23(8):1187-91. doi: 10.2337/diacare.23.8.1187.
PubMed 10937520
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
- ClinicalTrials.gov ID
- NCT01926522
- Acronym / sponsor ID
- Habilita-RAR-02
- Keywords
- Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Giovanni TaveggiaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 21 Aug 2013 (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 investigators evaluated the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
Detailed description
Recent studies witnessed how physical exercise may interrupt the devastating decrease of muscle performance in DSP and further experiments are underway to find more exercises for the recovery of motor function impairment. In fact the rehabilitation treatment, that aims at reducing motor disability, preserving gait functions and preventing falling risks, is an interesting therapeutic approach. Literature recommends balance re-training exercises, muscle strengthening, selective stretching and retraining of motor activity.
New technologies produced in the recent decades different devices used in strengthening exercises (electromechanical dynamometers), balance recovery (balance platforms) and gait (analyzing treadmills) have visual feedbacks through which the patients may independently monitor accuracy and intensity of their exercises, being therefore strongly motivated and resulting in a high training intensity. These technologies are often used in rehabilitation of different patients, but are rarely employed for DSP.
The purpose of this case control study was to examine the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technological Rehabilitation | Experimental | Device: Technological RehabilitationExperimental group receives a treatment of: 20 minutes of analyzing treadmill with feedback focused on symmetry and length of stride; 20 minutes of isokinetic dynamometric muscle strengthening of flexor and extensor muscles of tibiotarsal joint; 20 minutes of balance retraining on dynamic balance platform. Each patient receives 20 sessions over a period of 4 weeks (5 sessions per week). |
| Control Rehabilitation | Active comparator | Other: Control RehabilitationControl group receives the same number of treatment sessions of same duration as those in the experimental group: activities targeted to improve the endurance (instead of analyzing treadmill ), manual exercises of lower limb muscle strengthening, stretching exercises (instead of dynamometer), gait retraining on the floor for 20 minutes and static and dynamic balance exercises in upright position (instead of dynamic balance platform). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The participants need to have a history of diabetes mellitus type 2, >3 years, (i.e., time from the diagnosis or the beginning of first related signs or symptoms),
- A diagnosis of Distal Sensorimotor Polyneuropathy associated,
- Able to walk autonomously, eventually with a aid.
Key exclusion criteria (8 listed)
- Scoring less than 5 points on the Functional Independence Measure (FIM) (7) locomotion scale,
- Presenting articular ankyloses, contractures, spasms with important locomotion effects,
- Presenting bony instability affecting lower limb functionality (unconsolidated fractures, vertebral instability, severe osteoporosis),
- In presence of attendant clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and different other conditions),
- In presence of cutaneous lesions at lower limbs,
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 |
|---|---|---|
| Technological RehabilitationAlso: Dynamometric isokinetic device: Biodex System 4,, Balance device: Biodex Balance System SD,, Analyzing treadmill: Biodex Gait Trainer 3.The length of stride of reference used during the exercise is personalized and depends on the height of patients. Each patient carries out the feedback for 20 minutes with the aim of generating the most symmetric and regular gait. Patients, with the dynamometer, work on strengthening of flexor and extensor muscles with ankle speeds at 90°/sec and 120°/sec. The strengthening technique was performed twice for 10 minutes each time with a 1 minute rest between sets. The session ends with a 20-minute feedback on dynamic balance platform by carrying out exercises in which they need to reach randomly appearing targets. Subjects begin with 12 minutes the first 4 sessions, progress to 16 minutes the next 2 sessions, then 18' (2 sessions), and finally 20', if able, during the last 4 sessions. | Device | Technological Rehabilitation |
| Control RehabilitationAlso: Manual rehabilitation with the therapist.When needed, more than on e therapist are employed in the intervention for safety reasons. | Other | Control Rehabilitation |
Primary outcome
Change from Baseline of 6-minute walk test
Time frame: 1 day after the treatment
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance. The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
Change from Baseline of 10-metres walk test
Time frame: 1 day after the treatment
All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed. The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.
26 secondary outcomes
Followup change from Baseline of 6-minute walk test
Time frame: 30 days after the treatment
Followup change from Baseline of 10-metres walk test
Time frame: 30 days after the treatment
Change from Baseline of the Functional Independence Measure (FIM)
Time frame: 1 day after the treatment
Change from Baseline of the Tinetti scale
Time frame: 1 day after the treatment
Change from Baseline of the Resting Energy Expenditure (REE)
Time frame: 1 day after the treatment
Change from Baseline of the Respiratory Rate (RR)
Time frame: 1 day after the treatment
Change from Baseline of the Heart Rate (HR)
Time frame: 1 day after the treatment
Change from Baseline of the oxygen saturation (SpO2)
Time frame: 1 day after the treatment
Change from Baseline of the maximal oxygen consumption (VO2 max)
Time frame: 1 day after the treatment
Change from Baseline of the expired minute volume (Ve)
Time frame: 1 day after the treatment
Change from Baseline of the fraction of expired air that is oxygen (FeO2)
Time frame: 1 day after the treatment
Change from Baseline of the Systolic Blood Pressure (SBP)
Time frame: 1 day after the treatment
Change from Baseline of the Diastolic Blood Pressure (DBP)
Time frame: 1 day after the treatment
Change from Baseline of the Glycated Hemoglobin (HbA1c)
Time frame: 1 day after the treatment
Followup change from Baseline of the Functional Independence Measure (FIM)
Time frame: 30 days after the treatment
Followup change from Baseline of the Tinetti scale
Time frame: 30 days after the treatment
Followup change from Baseline of the Resting Energy Expenditure (REE)
Time frame: 30 days after the treatment
Followup change from Baseline of the Respiratory Rate (RR)
Time frame: 30 days after the treatment
Followup change from Baseline of the Heart Rate (HR)
Time frame: 30 days after the treatment
Followup change from Baseline of the oxygen saturation (SpO2)
Time frame: 30 days after the treatment
Followup change from Baseline of the maximal oxygen consumption (VO2 max)
Time frame: 30 days after the treatment
Followup change from Baseline of the expired minute volume (Ve)
Time frame: 30 days after the treatment
Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
Time frame: 30 days after the treatment
Followup change from Baseline of the Systolic Blood Pressure (SBP)
Time frame: 30 days after the treatment
Followup change from Baseline of the Diastolic Blood Pressure (DBP)
Time frame: 30 days after the treatment
Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
Time frame: 30 days after the treatment
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 24 Mar 2014.
- Background: PubMed 22271730Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.
- Background: PubMed 2815802Starling JR, Harms BA. Diagnosis and treatment of genitofemoral and ilioinguinal neuralgia. World J Surg. 1989 Sep-Oct;13(5):586-91. doi: 10.1007/BF01658875.
- Background: PubMed 21937901Ites KI, Anderson EJ, Cahill ML, Kearney JA, Post EC, Gilchrist LS. Balance interventions for diabetic peripheral neuropathy: a systematic review. J Geriatr Phys Ther. 2011 Jul-Sep;34(3):109-16. doi: 10.1519/JPT.0b013e318212659a.
- Background: PubMed 9135952Fedele D, Comi G, Coscelli C, Cucinotta D, Feldman EL, Ghirlanda G, Greene DA, Negrin P, Santeusanio F. A multicenter study on the prevalence of diabetic neuropathy in Italy. Italian Diabetic Neuropathy Committee. Diabetes Care. 1997 May;20(5):836-43. doi: 10.2337/diacare.20.5.836.
- Background: PubMed 15952441Aring AM, Jones DE, Falko JM. Evaluation and prevention of diabetic neuropathy. Am Fam Physician. 2005 Jun 1;71(11):2123-8.
- Background: PubMed 22971096Divisova S, Vlckova E, Hnojcikova M, Skorna M, Nemec M, Dubovy P, Dusek L, Jarkovsky J, Belobradkova J, Bednarik J. Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. J Peripher Nerv Syst. 2012 Sep;17(3):341-50. doi: 10.1111/j.1529-8027.2012.00420.x.
- Background: PubMed 23875837Spencer RJ, Wendell CR, Giggey PP, Katzel LI, Lefkowitz DM, Siegel EL, Waldstein SR. Psychometric limitations of the mini-mental state examination among nondemented older adults: an evaluation of neurocognitive and magnetic resonance imaging correlates. Exp Aging Res. 2013;39(4):382-97. doi: 10.1080/0361073X.2013.808109.
- Background: PubMed 12091180ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.
- Background: PubMed 22588756Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.
- Background: PubMed 22378478Nascimento LR, Caetano LC, Freitas DC, Morais TM, Polese JC, Teixeira-Salmela LF. Different instructions during the ten-meter walking test determined significant increases in maximum gait speed in individuals with chronic hemiparesis. Rev Bras Fisioter. 2012 Apr;16(2):122-7. doi: 10.1590/s1413-35552012005000008. Epub 2012 Mar 1. English, Portuguese.
- Background: PubMed 21755508Gomes AA, Onodera AN, Otuzi ME, Pripas D, Mezzarane RA, Sacco IC. Electromyography and kinematic changes of gait cycle at different cadences in diabetic neuropathic individuals. Muscle Nerve. 2011 Aug;44(2):258-68. doi: 10.1002/mus.22051.
- Background: PubMed 20965601van Sloten TT, Savelberg HH, Duimel-Peeters IG, Meijer K, Henry RM, Stehouwer CD, Schaper NC. Peripheral neuropathy, decreased muscle strength and obesity are strongly associated with walking in persons with type 2 diabetes without manifest mobility limitations. Diabetes Res Clin Pract. 2011 Jan;91(1):32-9. doi: 10.1016/j.diabres.2010.09.030. Epub 2010 Oct 20.
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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.
Giovanni Taveggia, MD principal investigator
Habilita, Ospedale di Sarnico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological Rehabilitation in people with Complications of Diabetes Mellitus and Diabetic Neuropathies, run by Giovanni Taveggia at 1 site in Italy.
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 3 inclusion and 8 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 24 Mar 2014. 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 Italy. 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?
Change from Baseline of 6-minute walk test (time frame: 1 day after the treatment). The study lists 2 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 NCT01926522, which also lists 14 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 24 Mar 2014.