Gait and Balance of Diabetes Type 2 Patients - Full Text View

Sponsor:	University Hospital, Geneva
Collaborators:	Maastricht University Medical Center Swiss Federal Institute of Technology EPFL Lausanne(CH)
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00637546

Purpose

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.

Condition	Intervention	Phase
Diabetes Type 2	Other: Physiotherapy	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Diabetic Nerve Problems Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Gait parameter: comfortable speed [ Time Frame: Before treatment / After treatment / 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other spatio temporal gait parameters and sagittal movement of lower limb [ Time Frame: Before Treatment/ After Treatment/ 6 month follow up ] [ Designated as safety issue: No ]
Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ] [ Designated as safety issue: No ]
Fear of falling (Falls efficacy scale) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ] [ Designated as safety issue: No ]

Enrollment:	71
Study Start Date:	September 2007
Study Completion Date:	March 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A,1 Physiotherapy	Other: Physiotherapy 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. Other Name: Physical Therapy

Arms

Assigned Interventions

Experimental: A,1

Physiotherapy

Other: Physiotherapy

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.

Other Name: Physical Therapy

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637546

Locations

Switzerland
University Hospital of Geneva
Geneva, Switzerland, 1205

Sponsors and Collaborators

University Hospital, Geneva

Maastricht University Medical Center

Swiss Federal Institute of Technology

EPFL Lausanne(CH)

Investigators

Principal Investigator:

Lara E Allet, MPtSc

University Hospital and University Geneva

More Information

Publications:

Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, Staal JB, de Bruin ED. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2009 Nov 17; [Epub ahead of print]

Allet L, Armand S, de Bie RA, Golay A, Pataky Z, Aminian K, de Bruin ED. Clinical factors associated with gait alterations in diabetic patients. Diabet Med. 2009 Oct;26(10):1003-9.

Allet L, Armand S, de Bie RA, Pataky Z, Aminian K, Herrmann FR, de Bruin ED. Gait alterations of diabetic patients while walking on different surfaces. Gait Posture. 2009 Apr;29(3):488-93. Epub 2009 Jan 9. Erratum in: Gait Posture. 2009 Oct;30(3):394.

Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, de Bruin ED. Reliability of diabetic patients' gait parameters in a challenging environment. Gait Posture. 2008 Nov;28(4):680-6. Epub 2008 Jun 25.

Allet L, Armand S, Golay A, Monnin D, de Bie RA, de Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008 Mar;24(3):173-91.

Turcot K, Allet L, Golay A, Hoffmeyer P, Armand S. Investigation of standing balance in diabetic patients with and without peripheral neuropathy using accelerometers. Clin Biomech (Bristol, Avon). 2009 Nov;24(9):716-21. Epub 2009 Aug 14.

Responsible Party:	Lara Allet (Mrs), University Hopsital Geneva
ClinicalTrials.gov Identifier:	NCT00637546 History of Changes
Other Study ID Numbers:	06-305
Study First Received:	March 11, 2008
Last Updated:	January 13, 2010
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:

Treatment
Efficacy
Diabetes
Gait
Balance

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Neuropathies
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications

ClinicalTrials.gov processed this record on February 09, 2012