Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

November 27, 2017 updated by: ASLIHAN UZUNKULAOGLU, Ufuk University

Effectiveness of Balance Training With Kinesthetic Ability Trainer-KAT2000 in Patients With Peripheral Neuropathic Pain: a Randomized Controlled Study

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06520
        • Ufuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

64 years to 87 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1
Exercise Only Group
Active Comparator: Group 2
Kinesthetic Ability Trainer Group
Other: Kinesthetic Ability Trainer
Kinesthetic Ability Trainer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Douleur Neuropathique 4
Time Frame: 1 months
Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain
1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: 1 months
for pain evaluation
1 months
Berg Balance Scale
Time Frame: 1 months
for balance evaluation
1 months
Time Up and Go Test
Time Frame: 1 months
for functional evaluation
1 months
Nottingham Health Profile
Time Frame: 1 months
for evaluation of quality of life
1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ufuk University

Investigators

  • Study Chair: Saime AY, Ufuk University
  • Study Chair: DUYGU KERİM, Ufuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

October 25, 2017

First Submitted That Met QC Criteria

November 27, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

December 2, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30112015-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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