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Gait and Balance of Diabetes Type 2 Patients

Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00637546
Enrollment
71
Registered
2008-03-18
Start date
2007-09-30
Completion date
2009-03-31
Last updated
2010-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Type 2

Keywords

Treatment, Efficacy, Diabetes, Gait, Balance

Brief summary

Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. It is estimated that the number of people with diabetes in the world will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional capacity and to minimise diabetes-related complications. The physiotherapist also has a role in providing advice about exercise and daily living activities. The fundamental principle of rehabilitation is to improve quality of life while diminishing the health care burden. By reducing the heightened risk of falling, the fall related injuries and the fear of falling one could improve quality of life in diabetic patients and reduce health care costs. The goal of this study is to investigate the effectiveness of gait and balance training in pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et al.(2002) and Page et al.(2002) The investigators randomly assign patients in a control group (no treatment) or in a treatment group. The treatment program consists of two group sessions per week over 12 weeks. Patients were encouraged to perform specific home exercises. After this 12-week program, patients were asked to continue their exercises. The effect of the treatment will be evaluated after the treatment program and after a 6-month follow up.

Interventions

OTHERPhysiotherapy

Gait and Balance training based on recommendations of Robertson et al. and Page et al. (different balance control exercises; progression in consecutive stages: Sensimotor training, a static phase, a dynamic phase combined with functional tasks. The treatment takes place twice a week over 12 weeks. Patients were encouraged to perform specific home exercises.

Sponsors

Maastricht University Medical Center
CollaboratorOTHER
Swiss Federal Institute of Technology
CollaboratorOTHER
Ecole Polytechnique Fédérale de Lausanne
CollaboratorOTHER
University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Past or present patient from the University Hospital in Geneva * Diagnosed with diabetes by the medical doctor (glycaemia \> 7 mmol on two different tests on an empty stomach) * Presence of a peripheral neuropathy (vibration perception ≤ 4)

Exclusion criteria

* Patients with a foot ulcer at the moment of intake * Patients with orthopaedic or chirurgical problems influencing gait parameters * Patients with a non diabetic neuropathy (Charcot, alcohol, Thyroid dysfunction) * Patients with neurological problems influencing gait parameters * Patients with incapacity to walk without a walking aid

Design outcomes

Primary

MeasureTime frame
Gait parameter: comfortable speedBefore treatment / After treatment / 6 month follow up

Secondary

MeasureTime frame
Other spatio temporal gait parameters and sagittal movement of lower limbBefore Treatment/ After Treatment/ 6 month follow up
Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)Before Treatment / After Treatment / 6 month follow up
Fear of falling (Falls efficacy scale)Before Treatment / After Treatment / 6 month follow up

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026