| CTRI Number |
CTRI/2024/07/070652 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Tele-physiotherapy for diabetic neuropathy patients in tertiary care center. |
|
Scientific Title of Study
|
Feasibility of telephysiotherapy on glucose control and physical performance in patients with diabetic peripheral neuropathy at tertiary care center- A Pilot Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deekshitha Y S |
| Designation |
Post Graduate |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research |
| Address |
Department of Physiotherapy Sri Devaraj Urs Academy of Higher Education and Research
RL Jalappa Hospital and Research Center Kolar KARNATAKA 563101 India |
| Phone |
9901446019 |
| Fax |
|
| Email |
deekshithays@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sarulatha H |
| Designation |
Professor |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research |
| Address |
Department of Physiotherapy Sri Devaraj URS Academy of Higher Education and Research Kolar KARNATAKA 563103 India |
| Phone |
9686235790 |
| Fax |
|
| Email |
charuparthe@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Deekshitha Y S |
| Designation |
Post Graduate |
| Affiliation |
Sri Devaraj URS Academy of Higher Education and Research |
| Address |
Department of Physiotherapy Sri Devaraj URS Academy of Higher Education and Research Kolar KARNATAKA 563103 India |
| Phone |
9901446019 |
| Fax |
|
| Email |
deekshithays@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Academy of higher Education and research, Tamaka, Kolar, Karnataka-563103, India |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Academy of higher Education and research |
| Address |
Tamaka, kolar, karnataka 563103 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deekshitha Y S |
R L Jalappa Hospital and Research Center |
Department of Physiotherapy, Ground Floor CARE Building, Tamaka, Kolar
Kolar Kolar KARNATAKA |
9448395235
deekshithays@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Faculty of Allied Heath & Basic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Telephysiotherapy |
On the first day of the session, the therapist will explain the exercises and also will make the patient perform the complete set of exercises. The exercise sessions are planned in such a way the first and last sessions will be on a site opd basis to asses’ pre- and post-outcome measures. All the other sessions will be through teletherapy weekly 1 session for 40- 50 minutes (3 to 4 days in a week) are planned for 3 months. On the first day, the patient will also be explained the requirements of tele physiotherapy and the exercise guidelines for performing the exercise during tele physiotherapy. So, on the alternative days, a specific appointment schedule will be given to each patient where the therapist will log in from our opd, and the participants will start attaining from the comfort of their homes through online platforms either in WhatsApp calls, zoom meetings or other video conference platforms suitable for both the participants. Now that the patient has some amount of knowledge about the exercise which is given on the first on-site from the second session onwards the Physiotherapist will once again explain and demonstrate with video and audio call and ensure the patient does the exercise securely. The home base exercises are prepared and validated in the department of physiotherapy and are also utilized for the previous studies based on the literature. The exercise includes aerobics, strengthening, mobility, stability, balance, coordination, and stretching exercises which are evidence to improve the physical functional parameters in diabetic peripheral neuropathy patients. Apart from the patient will also be asked to maintain a diary in which every day the patients challenges and improvements have been asked to record. On the days when tele physiotherapy sessions are not their patients, are advised to go for walking or cycling whichever they feel is safer for them and in the most comfortable environment or equipment feasible for them. On the last day session after the completion of 3 months, the patients are called to the site to assess the outcome parameters. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Eligible participants with mentioned age limit, both genders, diagnosed as diabetic peripheral neuropathy using MNSI |
|
| ExclusionCriteria |
| Details |
Presence of severe cardiovascular, respiratory, and other neurological diseases
Severe disability, severe balance impairments.
Who has visual, auditory, and cognitive impairments
Those unable or unwilling to comply with the required exercise will be excluded from the study |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HBA1c: for measuring the blood glucose levels |
Baseline, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short physical performance battery (SPPB): This includes gait speed, repeated chair stand test, & standing balance test |
Baseline & 12th week |
|
|
Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
31/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To determine the feasibility of a tele-physiotherapy program in diabetic peripheral neuropathy (DPN) patients. The purpose of this study is to determine the clinical effects of tele physical therapy intervention on glucose control, exercise capacity, and physical performance in patients with Diabetic Peripheral Neuropathy. Several literatures reported the effectiveness of exercises in controlling the complications of diabetes mellitus. DPN results in uncontrolled diabetes mellitus, lack of physical activities, poor lifestyle, and unawareness of exercise importance. Lack of compliance for exercise sessions among diabetic neuropathy patients. During our routine physiotherapy clinical services, it has been observed that the patient’s compliance with exercise sessions was poor with challenges including commuting to the center, dependency on family members, expenditure, etc. So, a physiotherapist provides remote care services to their patients through tele communication as they recognize the benefits that telehealth can bring such as cost savings, changes in their (exercise capacity), physical performance and quality of life, greater compliance with treatment plans, and a unique opportunity for to reach social disadvantage groups where cost, geographical location or cultural barriers may limit health services. So, a lack of regular supervised exercises can increase disease complications. The improvement in technology in the health field introduced tele physiotherapy, which has been effective in treating patients with various conditions and who have challenges being physically available. With the scope of literature reviewed, we observed only one literature on the use of tele rehab in Type 2 DM, in Western countries. Hence, this study intends to explore the use and feasibility of tele physiotherapy intervention with a focus on home-based exercises and education in DPN patients. The study will be started after obtaining ethical clearance from the institutional ethical committee. Study set up - R.L. Jalappa Hospital and Research Center. DPN patients will be contacted and those who consent to the study will be recruited. The participants will be recruited based on inclusion criteria. The variables mentioned will be documented during the initial contact with the patient. The outcome measures will be HBA1c level and short physical performance battery used for assessing the blood glucose level and physical performance in patients with DPN. The duration of the study will be three months weekly 1 session so total of 12 sessions. The time and date of the session will be informed before the start of the session. The follow-up of the included participants will be done by telephonic conversation. Home-based exercise guides using online platforms will be offered for 3 months. Glucose control and physical performance will be measured at baseline and after 12 weeks of sessions on an opd visit. Supervised Home exercise sessions to control diabetes and diabetic nerve damage offered through an online platform will make it easy and feasible for DPN patients to adhere to exercises. Hence the effects of exercise performance are expected to result in better glucose control and improved physical performance which include balance, flexibility, mobility, and stability and lower extremity functional capacity. The results of this study will also throw light on the feasibility, adherence, and effect of Tele physiotherapy as a safe and alternative treatment mode for DPN. In addition to this, telerehabilitation services can provide health benefits, and save time, labor, treatment costs, and health access for remote areas (rural communities.) Feasibility of setting the telerehabilitation services for DPN at RLJ center. Hence future studies should include the tele physiotherapy program for chronic DM patients. All information reporting on the feasibility, cost, access to rehabilitation services, and implementation process including the barriers and facilitators of telerehabilitation. |