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Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesthetic Ability Trainer
Sponsored by
Ufuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic Pain, Balance, Kinesthetic Ability Trainer, Quality of Life

Eligibility Criteria

64 Years - 87 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale.

Exclusion Criteria:

  • Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.

Sites / Locations

  • Ufuk University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

Exercise Only Group

Kinesthetic Ability Trainer Group

Outcomes

Primary Outcome Measures

Douleur Neuropathique 4
Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain

Secondary Outcome Measures

visual analogue scale
for pain evaluation
Berg Balance Scale
for balance evaluation
Time Up and Go Test
for functional evaluation
Nottingham Health Profile
for evaluation of quality of life

Full Information

First Posted
October 25, 2017
Last Updated
November 27, 2017
Sponsor
Ufuk University
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1. Study Identification

Unique Protocol Identification Number
NCT03359772
Brief Title
Kinesthetic Ability Trainer for Peripheral Neuropathic Pain
Official Title
Effectiveness of Balance Training With Kinesthetic Ability Trainer-KAT2000 in Patients With Peripheral Neuropathic Pain: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 1, 2016 (Actual)
Study Completion Date
April 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ufuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Neuropathic pain was determined by the Douleur Neuropathique 4 (DN4) questionnaire. Pain severity was assessed by using a visual analogue scale (VAS). KAT 2000 was used to evaluate static and dynamic balance. Dynamic balance and mobility also was assessed using the Berg Balance Scale (BBS) and Time Up and Go (TUG) test. QoL was assessed by using Nottingham Health Profile (NHP). Patients were evaluated at baseline and the end of the 4-week exercise program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic Pain, Balance, Kinesthetic Ability Trainer, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
No Intervention
Arm Description
Exercise Only Group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Kinesthetic Ability Trainer Group
Intervention Type
Other
Intervention Name(s)
Kinesthetic Ability Trainer
Intervention Description
Kinesthetic Ability Trainer
Primary Outcome Measure Information:
Title
Douleur Neuropathique 4
Description
Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain
Time Frame
1 months
Secondary Outcome Measure Information:
Title
visual analogue scale
Description
for pain evaluation
Time Frame
1 months
Title
Berg Balance Scale
Description
for balance evaluation
Time Frame
1 months
Title
Time Up and Go Test
Description
for functional evaluation
Time Frame
1 months
Title
Nottingham Health Profile
Description
for evaluation of quality of life
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
64 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DN4 scores ≥4 and moderately impaired balance with a score of 21-40 points on the Berg Balance Scale. Exclusion Criteria: Who had history of previous cerebrovascular events; other neurological, musculoskeletal, inner ear or eye disease that may lead to impaired vision or standing balance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DUYGU KERİM
Organizational Affiliation
Ufuk University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Saime AY
Organizational Affiliation
Ufuk University
Official's Role
Study Chair
Facility Information:
Facility Name
Ufuk University
City
Ankara
ZIP/Postal Code
06520
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

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