| CTRI Number |
CTRI/2025/08/092496 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"To see whether doing two things at once (dual task training) helps improve balance, coordination, and walking better than doing one thing at a time (single task training) in people with cerebellar ataxia."
|
|
Scientific Title of Study
|
To campare the effect of dual task training and single task training on balance, coordination and walking abilities in patients with cerebellar 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 |
Kirti |
| Designation |
PG student |
| Affiliation |
PGIMS, ROHTAK |
| Address |
College of physiotgerapy E Block,PGIMS, ROHTAK, HARYANA
Rohtak HARYANA 124001 India |
| Phone |
8295700775 |
| Fax |
|
| Email |
kirtisehrawat00@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Suman |
| Designation |
Associate professor |
| Affiliation |
PGIMS, ROHTAK |
| Address |
E block, college of physiotherapy, PGIMS Rohtak, HARYANA
Rohtak HARYANA 124001 India |
| Phone |
8814063412 |
| Fax |
|
| Email |
sumanmehra2017@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Kirti |
| Designation |
PG student |
| Affiliation |
PGIMS, ROHTAK |
| Address |
College of physiotherapy, E block PGIMS, ROHTAK, HARYANA
Rohtak HARYANA 124001 India |
| Phone |
8295700775 |
| Fax |
|
| Email |
kirtisehrawat00@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
college of physiotherapy |
| Address |
PGIMS, Rohtak |
| Type of Sponsor |
Government 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 |
| Kirti |
PGIMS Rohtak |
NEUROLOGY WARD,LALA SHYAMLAL BUILDING PGIMS, ROHTAK (124001)
COLLEGE OF PHYSIOTHERAPY, PGIMS ROHTAK (124001) Rohtak HARYANA |
08295700775
kirtisehrawat00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PANDIT BHAGWAT DAYAL SHARMA UNIVERSITY OF HEALTH SCIENCE,PGIMS Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G318||Other specified degenerative diseases of nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual task training |
Patient will perform cognitive task simultaneously with motor task ex: patient doing sit to stand, reaching arm in various direction on standing, lift up heels, load shift with contralateral leg flexion/extension, walking forward oblique, tandem walking and simultaneously doing word association, remember and answer, Repeating words, Answering simple question |
| Comparator Agent |
single task training |
Conventional treatment
In sitting position- seated on a stable surface with trunk unsupported (Side to side weight transfer, Trunk bending, Arm reaches, Foot circle Marching, Trunk rotation
In standing position- standing on a stable surface (Weight shift side-to-side, Arm raises, Trunk rotation, Standing with eyes closed)
Single task training group: Patient will perform only motor task ex: sit to stand, reaching arm in various direction on standing, lift up heels/tiptoes, lateral load shift with contralateral leg flexion/extension, walking forward oblique, tandem walking |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of ataxia with mobility ranging from a score of ‘2’ for question 1 ‘gait’ of the SARA scale
|
|
| ExclusionCriteria |
| Details |
1. any previous history of orthopedic problems severely impairing balance , gait or motor performance.
2. patient with severe visual impairment preventing exercise participation.
3. ear disease which causes vestibular ataxia.
4. patient with traumatic brain injury. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| berg balance scale, dynamic gait index, comprehensive coordination test, fall efficacy scale |
At baseline (day0), After 2 weeks, After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fall efficacy scale |
At baseline (day 0), After 2 weeks, After 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" 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
|
This study ’To compare the effect of dual-task training and single-task training on balance, coordination, and walking ability in patients with cerebellar ataxia’. Twenty participants were divided into two groups and trained for 4 weeks. The aim was to determine which method leads to greater improvement in functional mobility. The study hypothesizes that dual-task training may better reflect real-life challenges and lead to more significant improvements. |