Insoles Effect on Pain and Daily Activities
The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey
1 other identifier
interventional
89
1 country
1
Brief Summary
The aims of this study were to evaluate the effects of insoles on pain, daily activities and physical activity level, and to investigate the relation between satisfaction with the insoles and their actual use in individuals with LE pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 16, 2012
CompletedJuly 16, 2012
July 1, 2012
5 months
July 12, 2012
July 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Shoe insoles effect on pain level in lower extremities.
The participants answer the inetial questioniners before getting the insoles, then answr the same questionnier after four weeks of insoles use.
Four-weeks follwo up period
Shoe insoles effect on daily activities
The participants answer Inetnational Physical Activty Questionnier (IPAQ)and Lower Extremity Functional Status (LEFS)before getting the insoles and after four weeks of use.
Four-weeks follow up period
Satisfaction with shoe insoles use
Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.
After four weeks of use
Study Arms (1)
Single-arm study
OTHERThis is a single-arm study. Just one group (i.e. the patients)
Interventions
Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment.
Eligibility Criteria
You may qualify if:
- Pain in lower extremities
- Aged 18 years or older
- Able to speak Swedish.
You may not qualify if:
- Pain due to a systemic or progressive disease
- Use of orthosis of other type than insoles
- Earlier foot surgery or current use of prosthesis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre for Rehabilitation Research, Örebrolead
- Örebro County Councilcollaborator
Study Sites (1)
Dept. of Prosthetics and Orthotics, Orebro University Hospital
Örebro, Örebro County, 701 85, Sweden
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Amer, Master
Centre for Rehabilitation Reserach, Örebro
- STUDY DIRECTOR
Liselotte Norling-Hermansson, PhD
Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assisstant
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 16, 2012
Study Start
August 1, 2010
Primary Completion
January 1, 2011
Study Completion
November 1, 2011
Last Updated
July 16, 2012
Record last verified: 2012-07