Kinesthetic Ability Trainer for Peripheral Neuropathic Pain
Effectiveness of Balance Training With Kinesthetic Ability Trainer-KAT2000 in Patients With Peripheral Neuropathic Pain: a Randomized Controlled Study
1 other identifier
interventional
60
1 country
1
Brief Summary
Objective: To determine the effectiveness of balance training with Kinesthetic Ability Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance disorder. Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and gonarthrosis were included into this randomized controlled prospective study and randomized into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance exercises were given all patients in group 2 (n=30). All patients received 45-min individualized training session for three times a week for 4 weeks. Patients were evaluated according to pain, static and dynamic balance and quality of life (QoL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
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
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
December 2, 2017
CompletedDecember 2, 2017
November 1, 2017
2 months
October 25, 2017
November 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Douleur Neuropathique 4
Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain
1 months
Secondary Outcomes (4)
visual analogue scale
1 months
Berg Balance Scale
1 months
Time Up and Go Test
1 months
Nottingham Health Profile
1 months
Study Arms (2)
Group 1
NO INTERVENTIONExercise Only Group
Group 2
ACTIVE COMPARATORKinesthetic Ability Trainer Group
Interventions
Eligibility Criteria
You may qualify if:
- DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale.
You may not qualify if:
- Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ufuk Universitylead
Study Sites (1)
Ufuk University
Ankara, 06520, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
DUYGU KERİM
Ufuk University
- STUDY CHAIR
Saime AY
Ufuk University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ufuk University
Study Record Dates
First Submitted
October 25, 2017
First Posted
December 2, 2017
Study Start
January 1, 2016
Primary Completion
March 1, 2016
Study Completion
April 1, 2016
Last Updated
December 2, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share