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Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

Primary Purpose

Complications of Diabetes Mellitus, Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Technological Rehabilitation
Control Rehabilitation
Sponsored by
Giovanni Taveggia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications of Diabetes Mellitus focused on measuring Exercise Therapy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Habilita, Ospedale di Sarnico

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Technological Rehabilitation

Control Rehabilitation

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Change from Baseline of the Functional Independence Measure (FIM)
Change from Baseline of the Tinetti scale
Change from Baseline of the Resting Energy Expenditure (REE)
Change from Baseline of the Respiratory Rate (RR)
Change from Baseline of the Heart Rate (HR)
Change from Baseline of the oxygen saturation (SpO2)
Change from Baseline of the maximal oxygen consumption (VO2 max)
Change from Baseline of the expired minute volume (Ve)
Change from Baseline of the fraction of expired air that is oxygen (FeO2)
Change from Baseline of the Systolic Blood Pressure (SBP)
Change from Baseline of the Diastolic Blood Pressure (DBP)
Change from Baseline of the Glycated Hemoglobin (HbA1c)
Followup change from Baseline of the Functional Independence Measure (FIM)
Followup change from Baseline of the Tinetti scale
Followup change from Baseline of the Resting Energy Expenditure (REE)
Followup change from Baseline of the Respiratory Rate (RR)
Followup change from Baseline of the Heart Rate (HR)
Followup change from Baseline of the oxygen saturation (SpO2)
Followup change from Baseline of the maximal oxygen consumption (VO2 max)
Followup change from Baseline of the expired minute volume (Ve)
Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
Followup change from Baseline of the Systolic Blood Pressure (SBP)
Followup change from Baseline of the Diastolic Blood Pressure (DBP)
Followup change from Baseline of the Glycated Hemoglobin (HbA1c)

Full Information

First Posted
August 14, 2013
Last Updated
March 21, 2014
Sponsor
Giovanni Taveggia
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1. Study Identification

Unique Protocol Identification Number
NCT01926522
Brief Title
Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients
Official Title
Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Giovanni Taveggia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications of Diabetes Mellitus, Diabetic Neuropathies
Keywords
Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technological Rehabilitation
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Rehabilitation
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Technological Rehabilitation
Other Intervention Name(s)
Dynamometric isokinetic device: Biodex System 4,, Balance device: Biodex Balance System SD,, Analyzing treadmill: Biodex Gait Trainer 3.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Rehabilitation
Other Intervention Name(s)
Manual rehabilitation with the therapist.
Intervention Description
When needed, more than on e therapist are employed in the intervention for safety reasons.
Primary Outcome Measure Information:
Title
Change from Baseline of 6-minute walk test
Description
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.
Time Frame
1 day after the treatment
Title
Change from Baseline of 10-metres walk test
Description
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.
Time Frame
1 day after the treatment
Secondary Outcome Measure Information:
Title
Followup change from Baseline of 6-minute walk test
Description
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.
Time Frame
30 days after the treatment
Title
Followup change from Baseline of 10-metres walk test
Description
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.
Time Frame
30 days after the treatment
Title
Change from Baseline of the Functional Independence Measure (FIM)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Tinetti scale
Time Frame
1 day after the treatment
Title
Change from Baseline of the Resting Energy Expenditure (REE)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Respiratory Rate (RR)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Heart Rate (HR)
Time Frame
1 day after the treatment
Title
Change from Baseline of the oxygen saturation (SpO2)
Time Frame
1 day after the treatment
Title
Change from Baseline of the maximal oxygen consumption (VO2 max)
Time Frame
1 day after the treatment
Title
Change from Baseline of the expired minute volume (Ve)
Time Frame
1 day after the treatment
Title
Change from Baseline of the fraction of expired air that is oxygen (FeO2)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Systolic Blood Pressure (SBP)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Diastolic Blood Pressure (DBP)
Time Frame
1 day after the treatment
Title
Change from Baseline of the Glycated Hemoglobin (HbA1c)
Time Frame
1 day after the treatment
Title
Followup change from Baseline of the Functional Independence Measure (FIM)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Tinetti scale
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Resting Energy Expenditure (REE)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Respiratory Rate (RR)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Heart Rate (HR)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the oxygen saturation (SpO2)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the maximal oxygen consumption (VO2 max)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the expired minute volume (Ve)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Systolic Blood Pressure (SBP)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Diastolic Blood Pressure (DBP)
Time Frame
30 days after the treatment
Title
Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
Time Frame
30 days after the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Taveggia, MD
Organizational Affiliation
Habilita, Ospedale di Sarnico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Habilita, Ospedale di Sarnico
City
Sarnico
State/Province
Bergamo
ZIP/Postal Code
24067
Country
Italy

12. IPD Sharing Statement

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Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

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