Clinical trial NCT01926522: Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients
Official title: Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications of Diabetes Mellitus
Diabetic Neuropathies
Keywords: Exercise Therapy
Lead sponsor: Habilita, Ospedale di Sarnico
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline of 6-minute walk test
timeFrame: 1 day after the treatment
measure: Change from Baseline of 10-metres walk test
timeFrame: 1 day after the treatment
Secondary outcomes:
measure: Followup change from Baseline of 6-minute walk test
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of 10-metres walk test
timeFrame: 30 days after the treatment
measure: Change from Baseline of the Functional Independence Measure (FIM)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Tinetti scale
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Resting Energy Expenditure (REE)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Respiratory Rate (RR)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Heart Rate (HR)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the oxygen saturation (SpO2)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the maximal oxygen consumption (VO2 max)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the expired minute volume (Ve)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the fraction of expired air that is oxygen (FeO2)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Systolic Blood Pressure (SBP)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Diastolic Blood Pressure (DBP)
timeFrame: 1 day after the treatment
measure: Change from Baseline of the Glycated Hemoglobin (HbA1c)
timeFrame: 1 day after the treatment
measure: Followup change from Baseline of the Functional Independence Measure (FIM)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Tinetti scale
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Resting Energy Expenditure (REE)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Respiratory Rate (RR)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Heart Rate (HR)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the oxygen saturation (SpO2)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the maximal oxygen consumption (VO2 max)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the expired minute volume (Ve)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Systolic Blood Pressure (SBP)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Diastolic Blood Pressure (DBP)
timeFrame: 30 days after the treatment
measure: Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
timeFrame: 30 days after the treatment
Other outcomes:
Locations:
city: Sarnico
country: Italy
facility: Habilita, Ospedale di Sarnico
state: Bergamo
Study officials:
affiliation: Habilita, Ospedale di Sarnico
name: Giovanni Taveggia, MD
role: PRINCIPAL_INVESTIGATOR
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