Kinesthetic Ability Trainer for Peripheral Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359772
• Other study ID #: 30112015-4
• Status: Completed
• Phase: N/A
• First received: October 25, 2017
• Last updated: November 27, 2017
• Start date: January 1, 2016
• Est. completion date: April 1, 2016

Study information

• Verified date: November 2017
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 64 Years to 87 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Other:
• Kinesthetic Ability Trainer
Kinesthetic Ability Trainer

Locations

Country	Name	City	State
Turkey	Ufuk University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Douleur Neuropathique 4	Neuropathic pain questionnaire, if Douleur Neuropathique 4 value is 4 of more, there is neuropathic pain	1 months
Secondary	visual analogue scale	for pain evaluation	1 months
Secondary	Berg Balance Scale	for balance evaluation	1 months
Secondary	Time Up and Go Test	for functional evaluation	1 months
Secondary	Nottingham Health Profile	for evaluation of quality of life	1 months