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Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

NCT ID: NCT03359772

Last Updated: 2017-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2016-04-01

Brief Summary

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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

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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.

Conditions

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Neuropathic Pain

Keywords

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Neuropathic Pain Balance Kinesthetic Ability Trainer Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Exercise Only Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2

Kinesthetic Ability Trainer Group

Group Type ACTIVE_COMPARATOR

Kinesthetic Ability Trainer

Intervention Type OTHER

Kinesthetic Ability Trainer

Interventions

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Kinesthetic Ability Trainer

Kinesthetic Ability Trainer

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

64 Years

Maximum Eligible Age

87 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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ASLIHAN UZUNKULAOGLU

Ufuk University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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DUYGU KERİM

Role: STUDY_CHAIR

Ufuk University

Saime AY

Role: STUDY_CHAIR

Ufuk University

Locations

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Ufuk University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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30112015-4

Identifier Type: -

Identifier Source: org_study_id