NCT03359772

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

2 months

First QC Date

October 25, 2017

Last Update Submit

November 27, 2017

Conditions

Keywords

Neuropathic PainBalanceKinesthetic Ability TrainerQuality of Life

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 INTERVENTION

Exercise Only Group

Group 2

ACTIVE COMPARATOR

Kinesthetic Ability Trainer Group

Other: Kinesthetic Ability Trainer

Interventions

Kinesthetic Ability Trainer

Group 2

Eligibility Criteria

Age64 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Ufuk University

Ankara, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • DUYGU KERİM

    Ufuk University

    STUDY CHAIR
  • Saime AY

    Ufuk University

    STUDY CHAIR

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

Locations