Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

Diabetic Neuropathies Clinical Trial

Official title:

Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926522
• Other study ID #: Habilita-RAR-02
• Secondary ID: 2012061800074917
• Status: Completed
• Phase: N/A
• First received: August 14, 2013
• Last updated: March 21, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: March 2014
• Source: Habilita, Ospedale di Sarnico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications of Diabetes Mellitus
• Diabetes Complications
• Diabetic Neuropathies
• Polyneuropathies

Intervention

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

Locations

Country	Name	City	State
Italy	Habilita, Ospedale di Sarnico	Sarnico	Bergamo

Sponsors (1)

Lead Sponsor	Collaborator
Giovanni Taveggia

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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

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

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. — View Citation

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. Review. — View Citation

Corriveau H, Prince F, Hébert R, Raîche M, Tessier D, Maheux P, Ardilouze JL. Evaluation of postural stability in elderly with diabetic neuropathy. Diabetes Care. 2000 Aug;23(8):1187-91. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2012 Mar 1. English, Portuguese. — View Citation

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. — View Citation

Starling JR, Harms BA. Diagnosis and treatment of genitofemoral and ilioinguinal neuralgia. World J Surg. 1989 Sep-Oct;13(5):586-91. — View Citation

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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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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.	30 days after the treatment	No
Secondary	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.	30 days after the treatment	No
Secondary	Change from Baseline of the Functional Independence Measure (FIM)		1 day after the treatment	No
Secondary	Change from Baseline of the Tinetti scale		1 day after the treatment	No
Secondary	Change from Baseline of the Resting Energy Expenditure (REE)		1 day after the treatment	No
Secondary	Change from Baseline of the Respiratory Rate (RR)		1 day after the treatment	No
Secondary	Change from Baseline of the Heart Rate (HR)		1 day after the treatment	No
Secondary	Change from Baseline of the oxygen saturation (SpO2)		1 day after the treatment	No
Secondary	Change from Baseline of the maximal oxygen consumption (VO2 max)		1 day after the treatment	No
Secondary	Change from Baseline of the expired minute volume (Ve)		1 day after the treatment	No
Secondary	Change from Baseline of the fraction of expired air that is oxygen (FeO2)		1 day after the treatment	No
Secondary	Change from Baseline of the Systolic Blood Pressure (SBP)		1 day after the treatment	No
Secondary	Change from Baseline of the Diastolic Blood Pressure (DBP)		1 day after the treatment	No
Secondary	Change from Baseline of the Glycated Hemoglobin (HbA1c)		1 day after the treatment	No
Secondary	Followup change from Baseline of the Functional Independence Measure (FIM)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Tinetti scale		30 days after the treatment	No
Secondary	Followup change from Baseline of the Resting Energy Expenditure (REE)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Respiratory Rate (RR)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Heart Rate (HR)		30 days after the treatment	No
Secondary	Followup change from Baseline of the oxygen saturation (SpO2)		30 days after the treatment	No
Secondary	Followup change from Baseline of the maximal oxygen consumption (VO2 max)		30 days after the treatment	No
Secondary	Followup change from Baseline of the expired minute volume (Ve)		30 days after the treatment	No
Secondary	Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Systolic Blood Pressure (SBP)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Diastolic Blood Pressure (DBP)		30 days after the treatment	No
Secondary	Followup change from Baseline of the Glycated Hemoglobin (HbA1c)		30 days after the treatment	No