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Clinical Trials/NCT03359772
NCT03359772CompletedNot Applicable

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

Ufuk University1 site in 1 country60 target enrollmentStarted: January 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Douleur Neuropathique 4

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
64 Years to 87 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Group 1

No Intervention

Exercise Only Group

Group 2

Active Comparator

Kinesthetic Ability Trainer Group

Intervention: Kinesthetic Ability Trainer (Other)

Outcomes

Primary Outcomes

Douleur Neuropathique 4

Time Frame: 1 months

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

Secondary Outcomes

  • visual analogue scale(1 months)
  • Time Up and Go Test(1 months)
  • Berg Balance Scale(1 months)
  • Nottingham Health Profile(1 months)

Investigators

Sponsor
Ufuk University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ASLIHAN UZUNKULAOGLU

Ufuk University

Ufuk University

Study Sites (1)

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