Home » Trials » SLCTR/2023/017
Effectiveness of Proprioceptive Rehabilitation on Postural Stability and Quality of Life of Patients with Diabetic Polyneuropathy
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SLCTR Registration Number
SLCTR/2023/017
Date of Registration
The date of last modification
Sep 27, 2023
Scientific Title of Trial
Effectiveness of Proprioceptive Rehabilitation on Postural Stability and Quality of Life of Patients with Diabetic Polyneuropathy
Public Title of Trial
Effectiveness of 12-week proprioceptive rehabilitation over conventional rehabilitation in improving postural stability and quality of life of patients with diabetic polyneuropathy: A randomized-controlled trial
Disease or Health Condition(s) Studied
Diabetic polyneuropathy
Scientific Acronym
None
Public Acronym
None
Brief title
Proprioceptive rehabilitation for diabetic polyneuropathy; 2023/ERC/20: ERC. UoP
Universal Trial Number
U1111-1296-9238
Any other number(s) assigned to the trial and issuing authority
HDC/2020/ 06 by the Higher Degree Committee, University of Peradeniya
What is the research question being addressed?
Does proprioceptive rehabilitation improve the postural stability and quality of life of patients with diabetic polyneuropathy when compared to conventional rehabilitation?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Outcome assessors
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
A specially designed, evidence-based, novel proprioceptive rehabilitation program will be introduced and implemented among the intervention group, in which the participants will undergo specific exercises to improve lower limb static and dynamic proprioception for 45 minutes duration per day, twice a week for 12 weeks. The control group will undergo a conventional balance and strength training program for 45 minutes per day, twice a week for 12 weeks. Participants who will not be able to follow up the program continuously for more than three consecutive weeks will be disqualified to be included in the study. So their data will not be considered for the final data analysis. The study will be designed as a double blinded-RCT.’
Inclusion criteria
Male and female patients Patients with type-2 diabetes for one year or more Minimum age of 35 years and maximum age of 60 years
Exclusion criteria
Patients with a history of: • cardiovascular diseases • history of strokes in the past • autonomic dysfunctions • recent surgery • severe pain and paresthesia • other types of neuropathy • diabetic foot ulcers • impaired vision • significant psychiatric disorders • amputation • pregnant women • obese patients
Primary outcome(s)
|
1.
Postural stability will be measured by the Clinical Test of Sensory Interaction on Balance (CTSIB) |
[ At the baseline, 6 weeks after the commencement and at the end of 12 weeks ] |
Secondary outcome(s)
|
1.
Quality of life will be measured by 36-Item Short Form Survey (SF-36) |
[ At the baseline, 6 weeks after the commencement and at the end of 12 weeks ] |
Target number/sample size
120 (60 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2023-09-27
Anticipated end date
2024-01-20
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2023-07-26
Approval number
2023/ERC/20
Details of Ethics Review Committee
| Name: | Ethics Review Committee |
| Institutional Address: | Faculty of Medicine, University of Peradeniya |
| Telephone: | 0812396000 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
V.M.B.K.T.Malwanage
Lecturer (Probationary)
Department of Physiotherapy,
Faculty of Allied Health Sciences,
University of Peradeniya
+94 813999623
+94711404667
ktmalwanage@gmail.com. kavindaahs@ahs.pdn.ac.lk
Contact Person for Public Queries
Prof. S.D.I. Nanayakkara
Professor in Physiology
Department of Physiology,
Faculty of Medicine,
University of Peradeniya
+94 81 239 6298
induphysiology@yahoo.com’
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
