Gait and Balance of Diabetes Type 2 Patients

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637546
• Other study ID #: 06-305
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 11, 2008
• Last updated: January 13, 2010
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: March 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Geneva	EPFL Lausanne(CH), Maastricht University Medical Center, Swiss Federal Institute of Technology

Country where clinical trial is conducted

Switzerland, 

References & Publications (6)

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. doi: 10.1016/j.gaitpost.2008.05.006. Epub 2008 Jun 25. — View Citation

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. 2010 Mar;53(3):458-66. doi: 10.1007/s00125-009-1592-4. Epub 200 — View Citation

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. doi: 10.1111/j.1464-5491.2009.02811.x. — View Citation

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. doi: 10.1016/j.gaitpost.2008.11.012. Epub 2009 Jan 9. Erratum in: — View Citation

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-Apr;24(3):173-91. doi: 10.1002/dmrr.809. Review. — View Citation

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. doi: 10.1016/j.clinbiomech.2009.07.003. Epub 2009 Aug 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait parameter: comfortable speed		Before treatment / After treatment / 6 month follow up	No
Secondary	Other spatio temporal gait parameters and sagittal movement of lower limb		Before Treatment/ After Treatment/ 6 month follow up	No
Secondary	Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)		Before Treatment / After Treatment / 6 month follow up	No
Secondary	Fear of falling (Falls efficacy scale)		Before Treatment / After Treatment / 6 month follow up	No