Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

Giovanni Taveggia

Status: Completed

Conditions: Diabetic Neuropathies; Complications of Diabetes Mellitus

Treatments: Other: Control Rehabilitation; Device: Technological Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT01926522

Habilita-RAR-02

201206180007491711110 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Technological Rehabilitation

Experimental group

Description:

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).

Treatment:

Device: Technological Rehabilitation

Control Rehabilitation

Active Comparator group

Description:

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).

Treatment:

Other: Control Rehabilitation