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Completed

NCT Number: NCT01926522

Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Habilita, Ospedale di Sarnico

Sarnico, Bergamo, 24067, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Technological rehabilitation

Device

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.

Control Rehabilitation

Other

When needed, more than on e therapist are employed in the intervention for safety reasons.

Other names: Manual rehabilitation with the therapist.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Followup change from Baseline of 6-minute walk test

    Time frame: 30 days 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.

  2. Followup change from Baseline of 10-metres walk test

    Time frame: 30 days 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.

  3. Change from Baseline of the Functional Independence Measure (FIM)

    Time frame: 1 day after the treatment

  4. Change from Baseline of the Tinetti scale

    Time frame: 1 day after the treatment

  5. Change from Baseline of the Resting Energy Expenditure (REE)

    Time frame: 1 day after the treatment

  6. Change from Baseline of the Respiratory Rate (RR)

    Time frame: 1 day after the treatment

  7. Change from Baseline of the Heart Rate (HR)

    Time frame: 1 day after the treatment

  8. Change from Baseline of the oxygen saturation (SpO2)

    Time frame: 1 day after the treatment

  9. Change from Baseline of the maximal oxygen consumption (VO2 max)

    Time frame: 1 day after the treatment

  10. Change from Baseline of the expired minute volume (Ve)

    Time frame: 1 day after the treatment

  11. Change from Baseline of the fraction of expired air that is oxygen (FeO2)

    Time frame: 1 day after the treatment

  12. Change from Baseline of the Systolic Blood Pressure (SBP)

    Time frame: 1 day after the treatment

  13. Change from Baseline of the Diastolic Blood Pressure (DBP)

    Time frame: 1 day after the treatment

  14. Change from Baseline of the Glycated Hemoglobin (HbA1c)

    Time frame: 1 day after the treatment

  15. Followup change from Baseline of the Functional Independence Measure (FIM)

    Time frame: 30 days after the treatment

  16. Followup change from Baseline of the Tinetti scale

    Time frame: 30 days after the treatment

  17. Followup change from Baseline of the Resting Energy Expenditure (REE)

    Time frame: 30 days after the treatment

  18. Followup change from Baseline of the Respiratory Rate (RR)

    Time frame: 30 days after the treatment

  19. Followup change from Baseline of the Heart Rate (HR)

    Time frame: 30 days after the treatment

  20. Followup change from Baseline of the oxygen saturation (SpO2)

    Time frame: 30 days after the treatment

  21. Followup change from Baseline of the maximal oxygen consumption (VO2 max)

    Time frame: 30 days after the treatment

  22. Followup change from Baseline of the expired minute volume (Ve)

    Time frame: 30 days after the treatment

  23. Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)

    Time frame: 30 days after the treatment

  24. Followup change from Baseline of the Systolic Blood Pressure (SBP)

    Time frame: 30 days after the treatment

  25. Followup change from Baseline of the Diastolic Blood Pressure (DBP)

    Time frame: 30 days after the treatment

  26. Followup change from Baseline of the Glycated Hemoglobin (HbA1c)

    Time frame: 30 days after the treatment

Sponsors and collaborators

Lead sponsor

Giovanni Taveggia

Other

Registry information

Official study title

Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 21, 2013
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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