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Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

21 maart 2014 bijgewerkt door: Giovanni Taveggia

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
    • Bergamo
      • Sarnico, Bergamo, Italië, 24067
        • Habilita, Ospedale di Sarnico

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 85 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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).
Apparaat: 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.

Andere namen:
  • Dynamometric isokinetic device: Biodex System 4,
  • Balance device: Biodex Balance System SD,
  • Analyzing treadmill: Biodex Gait Trainer 3.
Actieve vergelijker: 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).
Ander: Control Rehabilitation
When needed, more than on e therapist are employed in the intervention for safety reasons.
Andere namen:
  • Manuele revalidatie met de therapeut.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change from Baseline of 6-minute walk test
Tijdsspanne: 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.
1 day after the treatment
Change from Baseline of 10-metres walk test
Tijdsspanne: 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.
1 day after the treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Followup change from Baseline of 6-minute walk test
Tijdsspanne: 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.
30 days after the treatment
Followup change from Baseline of 10-metres walk test
Tijdsspanne: 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.
30 days after the treatment
Change from Baseline of the Functional Independence Measure (FIM)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Tinetti scale
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Resting Energy Expenditure (REE)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Respiratory Rate (RR)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Heart Rate (HR)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the oxygen saturation (SpO2)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the maximal oxygen consumption (VO2 max)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the expired minute volume (Ve)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the fraction of expired air that is oxygen (FeO2)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Systolic Blood Pressure (SBP)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Diastolic Blood Pressure (DBP)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Change from Baseline of the Glycated Hemoglobin (HbA1c)
Tijdsspanne: 1 day after the treatment
1 day after the treatment
Followup change from Baseline of the Functional Independence Measure (FIM)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Tinetti scale
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Resting Energy Expenditure (REE)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Respiratory Rate (RR)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Heart Rate (HR)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the oxygen saturation (SpO2)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the maximal oxygen consumption (VO2 max)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the expired minute volume (Ve)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Systolic Blood Pressure (SBP)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Diastolic Blood Pressure (DBP)
Tijdsspanne: 30 days after the treatment
30 days after the treatment
Followup change from Baseline of the Glycated Hemoglobin (HbA1c)
Tijdsspanne: 30 days after the treatment
30 days after the treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Giovanni Taveggia

Onderzoekers

  • Hoofdonderzoeker: Giovanni Taveggia, MD, Habilita, Ospedale di Sarnico

Publicaties en nuttige links

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Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2013

Primaire voltooiing (Werkelijk)

1 november 2013

Studie voltooiing (Werkelijk)

1 november 2013

Studieregistratiedata

Eerst ingediend

14 augustus 2013

Eerst ingediend dat voldeed aan de QC-criteria

17 augustus 2013

Eerst geplaatst (Schatting)

21 augustus 2013

Updates van studierecords

Laatste update geplaatst (Schatting)

24 maart 2014

Laatste update ingediend die voldeed aan QC-criteria

21 maart 2014

Laatst geverifieerd

1 maart 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Habilita-RAR-02
  • 201206180007491711110 (Andere identificatie: Bioethic board)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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