| CTRI Number |
CTRI/2025/04/084868 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing dual task training and task oriented circuit training along with conventional therapy for improving balance in ataxia patients |
|
Scientific Title of Study
|
To compare the effectiveness of dual task training versus task oriented circuit training along with conventional therapy on balance in patients with ataxia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Kandwal |
| Designation |
Post graduate student |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9389371664 |
| Fax |
|
| Email |
poojakandwal1504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Niraj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
7895795277 |
| Fax |
|
| Email |
drnirajkumar25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tabassum PT |
| Designation |
Assistant Professor |
| Affiliation |
Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Shri Guru Ram Rai University, school of paramedical and allied health sciences.
Dehradun
UTTARANCHAL
248001
India |
| Phone |
9340473424 |
| Fax |
|
| Email |
drtabassumazm22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Dehradun UTTARANCHAL 248001 India |
|
|
Primary Sponsor
|
| Name |
Pooja Kandwal |
| Address |
Shri Mahant Indresh Hospital Department of Physiotherapy North Block, Basement Dehradun UTTARANCHAL 248001 India
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Dr Niraj Kumar |
Shri Mahant Indresh Hospital |
Shri Mahant Indresh Hospital, Department of Physiotherapy, North Block, Basement,248001
Dehradun
UTTARANCHAL |
7895795277
drnirajkumar25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R270||Ataxia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual Task Training with Conventional Therapy |
These patients are first treated with conventional therapy for 20 min which includes Active ROM exercises of Hip, Knee and Ankle joint, Assisted calf and hamstring Stretching, Static postural control exercises and Dual Task Training for 25 min which combines balance exercises like sit to stand, standing with open eyes, tandem walking etc with cognitive tasks like memory recall, problem solving etc. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Task Oriented Circuit Training with Conventional Therapy |
These patients are first treated with conventional therapy for 20 min which includes Active ROM exercises of Hip, Knee and Ankle joint, Assisted calf and hamstring Stretching, Static postural control exercises and Task Oriented Circuit Training for 25 min which incorporates functional tasks like sitting in various chair heights then stand up, walk a short distance(3m) then return back, Standing with base of support gradually constrained, descending down to floor to reach object etc. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Confirm diagnosis of ataxia (of any type) by clinician
Mild to moderate ataxia (BBS scores of 31-50)
Able to maintain independent static standing balance with eye open for 5 min without assisted device
Able to walk independently with or without
walking aids
Mini -Mental State Examination (MMSE)minimum score 24
Those willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Bed ridden; wheel chair bounded patients,
Symptom of unstable cardiac disease, atrial fibrillation
Uncontrolled hypertension
Recent pulmonary embolism
Having orthopedic impairment like recent lower limb fracture, severe joint disorders(Advanced osteoarthritis, rheumatoid arthritis) etc.
Severe visual, hearing impairment preventing from exercise participation
Severe cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
SARA (Severity of ataxia scale)
Quality of life scale (Euro Qol 5 dimension 5 level) |
Baseline, 6th week, 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2025 |
| 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 Applicable |
| 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
|
This study aims to compare the effectiveness of Dual Task Training versus Task Oriented Circuit Training, both combined with conventional therapy, in improving balance in patients with ataxia. It is a comparative experimental study involving 58 participants aged 18 to 60 years with mild to moderate ataxia, randomly assigned to two groups: Group A that is DTT along with conventional therapy and Group B TOCT along with conventional therapy. The interventions will be administered over 12 weeks, with assessments at baseline, 6 weeks, and 12 weeks using the Berg Balance Scale, Severity of Ataxia Rating Scale, and EQ 5D 5L. The study hypothesizes that one intervention will be statistically superior to the other in improving balance, with the null hypothesis stating no significant difference. DTT involves simultaneous motor and cognitive tasks, while TOCT focuses on functional circuit based exercises. Conventional therapy includes stretching, strengthening, and postural control exercises. Participants will be recruited from Shri Mahant Indiresh Hospital’s Physiotherapy OPD or IPD, with strict inclusion like independent standing/walking, MMSE more than equal to 24, and exclusion like severe comorbidities, cognitive/sensory impairments criteria. The primary outcomes are balance improvement BBS and SARA, while the secondary outcome is quality of life EQ 5D 5L. The total duration is 6 months, with G Power analysis effect size 0.48, 90 percentage power justifying the sample size. |