| CTRI Number |
CTRI/2023/05/053338 [Registered on: 31/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
EFFECT OF DOUBLE TASK EXERCISES VS SIMILARITY EXERCISES ON WALKING SPEED AND BALANCE IN OLDER PEOPLE.
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Scientific Title of Study
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“EFFECT OF DUAL TASK TRAINING VERSUS ANALOGY TRAINING ON GAIT SPEED AND BALANCE IN OLDER ADULTS.â€
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| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Chetana tetgure |
| Designation |
Post graduate |
| Affiliation |
Dr.D.Y.Patil college of physiotherpy,Pimpri |
| Address |
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Pune MAHARASHTRA 411018 India |
| Phone |
7304681063 |
| Fax |
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| Email |
chetanatetgure20@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Reema Joshi |
| Designation |
Associate professor |
| Affiliation |
Dr.D.Y.Patil college of physiotherpy,Pimpri |
| Address |
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Pune MAHARASHTRA 411018 India |
| Phone |
9890437630 |
| Fax |
|
| Email |
reema.joshi@dpu.edu.in |
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Details of Contact Person Public Query
|
| Name |
Chetana tetgure |
| Designation |
Post graduate |
| Affiliation |
Dr.D.Y.Patil college of physiotherpy,Pimpri |
| Address |
Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Dr.D.Y.Patil college of physiotherpy Pimpri. 190, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 Pune MAHARASHTRA 402104 India |
| Phone |
7304681063 |
| Fax |
|
| Email |
chetanatetgure20@gmail.com |
|
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Source of Monetary or Material Support
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| Dr. D.Y.Patil college of physiotherpy, Pimpri Pune. |
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Primary Sponsor
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| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| CHETANA TETGURE |
Dr.D.Y.Patil college of Physiotherapy, pimpri |
Ground floor 1 cabin , Dr.D.Y.Patil college of Physiotherapy ,Sant tukaram nagar , Pimpri,Pune . Pune MAHARASHTRA |
7304681063
chetanatetgure20@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee of DR.D.Y.patil college of Physiotherapy,Pune |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy volunteers |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Analogy training |
3 session/ week
1st week-walk as if you follow footprints.
2nd week- Try to cross a small bridge
3rd week-walk as if you are
Crossing the signal on road
4th week-walk imagining you are kicking a football in front of you.
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| Comparator Agent |
Control group |
- Walking advice and conventional therapy |
| Intervention |
Dual task |
3 session/ week
1st week- walk with counting backwards.
2nd week- Walk with counting backwards ,Obstacles walking,Speed alterations
3rd week- Walk with counting backwards,Zic sac patterns,Speed alteration
4th week-Walk with counting backwards,Figure of 8 patterns
Speed alteration
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Inclusion Criteria
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| Age From |
65.00 Year(s) |
| Age To |
74.00 Year(s) |
| Gender |
Both |
| Details |
1)Both male and female .
2) subject youngest old adults .
3) Mini Mental State Examination score 24 or higher out of 30
4) Tinetti’s Performance Oriented Mobility Assessment Scale (POMA) score higher than 19 out of 28.
5) Time up and go test score more than 20 secs .
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| ExclusionCriteria |
| Details |
1)Neurological impairments
2)Recent fracture
3)Visual impairments.( which cannot be corrected by glass)
4) vestibular impairment
5) Use of assistive device (cane, walker)
6) cognitive impairments
7) Presence of artificial prosthesis
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Method of Generating Random Sequence
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Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
1. 10 meter walk test
2. Time up and go test
3. Mini Mental state examination scale
4. Tinetti’s Performance Oriented Mobility Assessment scale (POMA)
5.Modified fall efficacy scale
6. Activities-Specific Balance confidence scale
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At the beginning and at the end of the study ( 4 weeks)
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Secondary Outcome
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| Outcome |
TimePoints |
| Not applicable |
Not applicable |
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Target Sample Size
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Total Sample Size="69" Sample Size from India="69"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 1 |
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Date of First Enrollment (India)
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10/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0" Months="6" Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Successful aging suffer less from declining abilities and enjoy a relatively higher level of cognitive wellness through the reorganization of brain networks. While, cognitive aging is typically associated with reductions of attention and memory capacities. Aging also can affect attention capacity ,executive control, working memory, processing speed and episodic memory which results poorer working memory, and poor processing speed .which also can affect the walking pattern in older adults. Walking is a complex process involving the interaction of neuromuscular, sensory, and cognitive functions, all of which deteriorate with aging. Both cognitive and motor task impact the walking performance, including decreased speed, increased stride time and stride time variability, especially in the older population. Which can lead to falls, reduced confidence, reduced functional mobility and quality of life in older adults. Therefore, there is a need to develop interventions to improve walking performance in older adults. Cognitive strategies, such as attentional strategies (self-generated with an internal focus), the use of external cues (auditory, visual or tactile), or self-instruction strategies can be beneficial in improving gait. Using motor learning strategies with cognitive function can strengthen working memory, increase processing speed and to improve multitasking performance. Implicit motor learning strategies describe as learning that progress with non or minimal increase in verbal knowledge of movement performance without awareness. Practical approach to use implicit motor learning is using analogies. Prefrontal cortex (PFC) plays a crucial role in cognitive function and was evident to be involved in dual tasking. Increased activation in PFC was observed during dual task walking healthy adults, and older adults tended to activate more compared to younger participants. Other Motor brain areas such as premotor cortex (PMC) and supplemental motor area (SMA) were also found to activate during dual task walking, which were responsible for stabilizing gait and adapting walking speed. Hence there is need to explore the potential impact of dual-task, analogy training on rehabilitation outcomes it could provide practical insights for the development of future therapeutic interventions for fall prevention programs.
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