Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

NCT01926522 | Completed DMC

• 2 other identifiers: Habilita-RAR-02201206180007491711110
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications of Diabetes Mellitus; Diabetic Neuropathies

Keywords

Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  1 day after the treatment

• 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.

  1 day after the treatment

Secondary Outcomes (26)

• Followup change from Baseline of 6-minute walk test

  30 days after the treatment

• Followup change from Baseline of 10-metres walk test

  30 days after the treatment

• Change from Baseline of the Functional Independence Measure (FIM)

  1 day after the treatment

• Change from Baseline of the Tinetti scale

  1 day after the treatment

• Change from Baseline of the Resting Energy Expenditure (REE)

  1 day after the treatment

Study Arms (2)

Technological Rehabilitation

EXPERIMENTAL

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

Control Rehabilitation

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Dynamometric isokinetic device: Biodex System 4,, Balance device: Biodex Balance System SD,, Analyzing treadmill: Biodex Gait Trainer 3.

Technological Rehabilitation

Control Rehabilitation OTHER

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

Also known as: Manual rehabilitation with the therapist.

Control Rehabilitation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giovanni Taveggia: lead

Study Sites (1)

Habilita, Ospedale di Sarnico

Sarnico, Bergamo, 24067, Italy

Location

Related Publications (14)

• Andersen H. Motor dysfunction in diabetes. Diabetes Metab Res Rev. 2012 Feb;28 Suppl 1:89-92. doi: 10.1002/dmrr.2257.

  PMID: 22271730 BACKGROUND

• Starling JR, Harms BA. Diagnosis and treatment of genitofemoral and ilioinguinal neuralgia. World J Surg. 1989 Sep-Oct;13(5):586-91. doi: 10.1007/BF01658875.

  PMID: 2815802 BACKGROUND

• Ites KI, Anderson EJ, Cahill ML, Kearney JA, Post EC, Gilchrist LS. Balance interventions for diabetic peripheral neuropathy: a systematic review. J Geriatr Phys Ther. 2011 Jul-Sep;34(3):109-16. doi: 10.1519/JPT.0b013e318212659a.

  PMID: 21937901 BACKGROUND

• Fedele D, Comi G, Coscelli C, Cucinotta D, Feldman EL, Ghirlanda G, Greene DA, Negrin P, Santeusanio F. A multicenter study on the prevalence of diabetic neuropathy in Italy. Italian Diabetic Neuropathy Committee. Diabetes Care. 1997 May;20(5):836-43. doi: 10.2337/diacare.20.5.836.

  PMID: 9135952 BACKGROUND

• Aring AM, Jones DE, Falko JM. Evaluation and prevention of diabetic neuropathy. Am Fam Physician. 2005 Jun 1;71(11):2123-8.

  PMID: 15952441 BACKGROUND

• Divisova S, Vlckova E, Hnojcikova M, Skorna M, Nemec M, Dubovy P, Dusek L, Jarkovsky J, Belobradkova J, Bednarik J. Prediabetes/early diabetes-associated neuropathy predominantly involves sensory small fibres. J Peripher Nerv Syst. 2012 Sep;17(3):341-50. doi: 10.1111/j.1529-8027.2012.00420.x.

  PMID: 22971096 BACKGROUND

• Spencer RJ, Wendell CR, Giggey PP, Katzel LI, Lefkowitz DM, Siegel EL, Waldstein SR. Psychometric limitations of the mini-mental state examination among nondemented older adults: an evaluation of neurocognitive and magnetic resonance imaging correlates. Exp Aging Res. 2013;39(4):382-97. doi: 10.1080/0361073X.2013.808109.

  PMID: 23875837 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

• Bennell K, Dobson F, Hinman R. Measures of physical performance assessments: Self-Paced Walk Test (SPWT), Stair Climb Test (SCT), Six-Minute Walk Test (6MWT), Chair Stand Test (CST), Timed Up & Go (TUG), Sock Test, Lift and Carry Test (LCT), and Car Task. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S350-70. doi: 10.1002/acr.20538. No abstract available.

  PMID: 22588756 BACKGROUND

• Nascimento LR, Caetano LC, Freitas DC, Morais TM, Polese JC, Teixeira-Salmela LF. Different instructions during the ten-meter walking test determined significant increases in maximum gait speed in individuals with chronic hemiparesis. Rev Bras Fisioter. 2012 Apr;16(2):122-7. doi: 10.1590/s1413-35552012005000008. Epub 2012 Mar 1. English, Portuguese.

  PMID: 22378478 BACKGROUND

• Gomes AA, Onodera AN, Otuzi ME, Pripas D, Mezzarane RA, Sacco IC. Electromyography and kinematic changes of gait cycle at different cadences in diabetic neuropathic individuals. Muscle Nerve. 2011 Aug;44(2):258-68. doi: 10.1002/mus.22051.

  PMID: 21755508 BACKGROUND

• van Sloten TT, Savelberg HH, Duimel-Peeters IG, Meijer K, Henry RM, Stehouwer CD, Schaper NC. Peripheral neuropathy, decreased muscle strength and obesity are strongly associated with walking in persons with type 2 diabetes without manifest mobility limitations. Diabetes Res Clin Pract. 2011 Jan;91(1):32-9. doi: 10.1016/j.diabres.2010.09.030. Epub 2010 Oct 20.

  PMID: 20965601 BACKGROUND

• Thomas T, Schreiber G. Acute-phase response of plasma protein synthesis during experimental inflammation in neonatal rats. Inflammation. 1985 Mar;9(1):1-7. doi: 10.1007/BF00915406.

  PMID: 2579907 BACKGROUND

• Corriveau H, Prince F, Hebert R, Raiche M, Tessier D, Maheux P, Ardilouze JL. Evaluation of postural stability in elderly with diabetic neuropathy. Diabetes Care. 2000 Aug;23(8):1187-91. doi: 10.2337/diacare.23.8.1187.

  PMID: 10937520 BACKGROUND

MeSH Terms

Conditions

Diabetes Complications; Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Giovanni Taveggia, MD

  Habilita, Ospedale di Sarnico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 21, 2013
• Study Start: September 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 24, 2014

Record last verified: 2014-03

Locations

IT (1)