Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giovanni Taveggia, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier:
NCT01926522
First received: August 14, 2013
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Complications of Diabetes Mellitus
Diabetic Neuropathies
Device: Technological Rehabilitation
Other: Control Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic

Resource links provided by NLM:


Further study details as provided by Habilita, Ospedale di Sarnico:

Primary Outcome Measures:
  • Change from Baseline of 6-minute walk test [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]

    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) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Tinetti scale [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Resting Energy Expenditure (REE) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Respiratory Rate (RR) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Heart Rate (HR) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the oxygen saturation (SpO2) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the maximal oxygen consumption (VO2 max) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the expired minute volume (Ve) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the fraction of expired air that is oxygen (FeO2) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Systolic Blood Pressure (SBP) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Diastolic Blood Pressure (DBP) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Change from Baseline of the Glycated Hemoglobin (HbA1c) [ Time Frame: 1 day after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Functional Independence Measure (FIM) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Tinetti scale [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Resting Energy Expenditure (REE) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Respiratory Rate (RR) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Heart Rate (HR) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the oxygen saturation (SpO2) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the maximal oxygen consumption (VO2 max) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the expired minute volume (Ve) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the fraction of expired air that is oxygen (FeO2) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Systolic Blood Pressure (SBP) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Diastolic Blood Pressure (DBP) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]
  • Followup change from Baseline of the Glycated Hemoglobin (HbA1c) [ Time Frame: 30 days after the treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: September 2013
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Technological Rehabilitation
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).
Device: Technological Rehabilitation

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.

Other Names:
  • Dynamometric isokinetic device: Biodex System 4,
  • Balance device: Biodex Balance System SD,
  • Analyzing treadmill: Biodex Gait Trainer 3.
Active Comparator: Control Rehabilitation
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).
Other: Control Rehabilitation
When needed, more than on e therapist are employed in the intervention for safety reasons.
Other Name: Manual rehabilitation with the therapist.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01926522

Locations
Italy
Habilita, Ospedale di Sarnico
Sarnico, Bergamo, Italy, 24067
Sponsors and Collaborators
Giovanni Taveggia
Investigators
Principal Investigator: Giovanni Taveggia, MD Habilita, Ospedale di Sarnico
  More Information

Publications:

Responsible Party: Giovanni Taveggia, MD, Habilita, Ospedale di Sarnico
ClinicalTrials.gov Identifier: NCT01926522     History of Changes
Other Study ID Numbers: Habilita-RAR-02, 201206180007491711110
Study First Received: August 14, 2013
Last Updated: March 21, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Habilita, Ospedale di Sarnico:
Exercise Therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetic Neuropathies
Polyneuropathies
Diabetes Complications
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014