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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01361906
Other study ID # REHSAM/11
Secondary ID
Status Completed
Phase Phase 4
First received May 25, 2011
Last updated May 28, 2014
Start date September 2010
Est. completion date February 2012

Study information

Verified date May 2014
Source Centre for Rehabilitation Research, Örebro
Contact n/a
Is FDA regulated No
Health authority Sweden: Vårdalstiftelsen
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether sensomotoric training can reduce neck/scapular pain in people with visual disability.


Description:

People with prolonged musculoskeletal disorders have impaired quality of life, physical function, work conditions and work ability and consume substantial public resources. An often overlooked fact in this context is the relationship between musculoskeletal disorders and the importance of a normally functioning visual system. People who have a visual impairment in adulthood often experience reduced health and life satisfaction. Many people lose their faith in order to continue with the activities previously carried out as to cope with their life, their work, and in some cases,personal care. Rehabilitative efforts to reduce the negative effects often involve the prescription of various visual aids which, in turn, often leads to unfavourable ergonomic and static postures with further increased risk of musculoskeletal problems. A prevention of such disorders is likely to allow them to continue their work, which is important from both an individual and a society perspective. The overall objective of the project is to evaluate the effects of an intervention program and develop a theoretical model for the relationship between near work, eye disorders and musculoskeletal disorders. The intervention is to be evaluated in a randomized trial on people with impaired vision and pain in the neck and scapular area. An intervention based on development and adaptation of an established physiotherapy practice in order to increase body awareness, body control and movement patterns will be evaluated. The effects of the intervention will be measured by a variety of outcome measures derived from WHO's ICF-model. An innovative solution for establishing proprioception and eye-hand coordination in everyday activities, the Clinical Kinematic Assessment Tool, will be used.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 67 Years
Eligibility Inclusion Criteria:

- visual disability

- age 18 to 67 years old

- pain in neck/scapular area

- living in Örebro county

Exclusion Criteria:

- deafness

- musculoskeletal disease (such as Multiple sclerosis, etc)

Study Design

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


Related Conditions & MeSH terms


Intervention

Behavioral:
Sensomotoric training
The intervention will be given once a week (2h per occasion) for twelve weeks. Each occasion is planned to have the following structure: 10 min initial conversation about how participants are feeling today and how it felt after the last time. 70 min guided sensory motor learning. 10 min final talks, reflections on how it felt today.

Locations

Country Name City State
Sweden Hälsobro Orebro Orebro County

Sponsors (3)

Lead Sponsor Collaborator
Centre for Rehabilitation Research, Örebro Örebro County Council, University of Gavle

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in neck/scapular pain at 12 month Physiotherapeut palpation of left and right M.Trapezius, M.Occiput, and M.Levator scapulae. Patient rate degree of pain on 100 mm VAS. baseline and 12 months No
Secondary Change from Baseline in sick leave at 12 month Patient self reported sick leave and sickleave registered at persons employer (if any) and/or at the Swedish Social Insurance Agency baseline and 12 month No