- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05775315
Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP
Additional Effects of Visual Feedback Along With Action Observation Therapy on Balance, Mobility and Cognition in Cerebral Palsy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: imran amjad
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Rawalpindi, Punjab, Pakistan, 46000
- Center for Profound Education Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Without visual impairment and visual field defects
- Mini-Mental state examination for Children (MMC) score >25
- GMFCS (gross motor function classification system) I-III
- Children with Modified Ashworth Scale (MAS) less than 2
Exclusion Criteria:
- Unable to walk
- Children with severe co-morbidities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Action Observation Therapy
exercises of AO protocol
|
Exercises of AO protocol MOVEMENT TOTAL VIDEO TIME PATIENT TIME Upright the pelvis 1 minute 5 minutes Move weight forward 1 minute 5 minutes Move weight to the left and right 1 minute 5 minutes Rotate right and left 1 minute 5 minutes Upright the pelvis in sitting position 1 minute 5 minutes Move weight forward from a sitting position 1 minute 5 minutes Stand up from a sitting position 1 minute 5 minutes Move weight right and left 1 minute 5 minutes Forward weight shift with right foot and left foot 1 minute 5 minutes Walking sideways to left 1 minute 5 minutes Walking sideways to right 1 minute 5 minutes Rest time between watching and performing each video will be 1 minute. the exercises will be done 3 times a week. |
Active Comparator: Visual feedback and Action Observation Therapy
Excercises of AO protocol infront of a mirror
|
Exercises of AO protocol in front of a mirror MOVEMENT TOTAL VIDEO TIME PATIENT TIME Upright the pelvis 1 minute 5 minutes Move weight forward 1 minute 5 minutes Move weight to the left and right 1 minute 5 minutes Rotate right and left 1 minute 5 minutes Upright the pelvis in sitting position 1 minute 5 minutes Move weight forward from a sitting position 1 minute 5 minutes Stand up from a sitting position 1 minute 5 minutes Move weight right and left 1 minute 5 minutes Forward weight shift with right foot and left foot 1 minute 5 minutes Walking sideways to left 1 minute 5 minutes Walking sideways to right 1 minute 5 minutes Rest time between watching and performing each video will be 1 minute. the exercises will be done 3 times a week. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gross Motor Function Classification Scale (GMFCS)
Time Frame: 12 weeks
|
Gross Motor Function measure (GMFM) is the valid and standard observational instrument to measure change in gross motor function in CP children.
The tool consists of 66 items with 5 dimensions.
These dimensions are the major motor functions i.e. supine/rolling, sitting, crawling/kneeling, standing and walking/running/jumping.
Each task is rated according to the scoring guidelines i.e. higher score indicated better gross motor function.
Each GMFM item is graded on 4-point scale i.e. 0 for unable to initiate the task, 1 for able to initiate the task, 2 for able to perform the task partially and 3 for able to perform the task completely.
At the end these score summed up into total score.
The component B,C,D and E of GMFCS will be used in this study respectively.
|
12 weeks
|
Pediatric Balance Scale (PBS)
Time Frame: 12 weeks
|
PBS is a modified form of Berg Balance Scale (BSS) which was developed for balance measurement in CP child.
It can be performed without specialized equipment and is easy to administrate.
It includes 14 items with 5-level grading to assess the functional activities that child must safely and independently form at home, community, activities including sitting balance, sit to stand/stand to sit, transfer, stepping, reaching forward, reaching to floor, turning and stepping on and off at elevated surface.
Each activity is rated according to scale from 0 to 4 i.e. 0 for unable to perform and 4 for able to perform without difficulty.
|
12 weeks
|
Timed 10-meter walk test
Time Frame: 12 weeks
|
The test can be used to measure the gait ability and speed.
The acceleration area 2.5m and deceleration area 2.5m can be marked on the ground as start and end point for the test.
Participants are asked to walk for 15 minutes on comfortable flat floor at a comfortable speed and then the walking speed is recorded through stopwatch over 10 m between these points.
The mean value of the three trials was used and expressed as m/s(14).
|
12 weeks
|
Mini Mental State Exam
Time Frame: 12 weeks
|
It is a cognitive screening task and scoring system for 3 to 14 years old child (25).
It is presented by 11 questions involving five basic cognitive abilities i.e. attention-concentration, orientation, registration, recall and language and constructive ability.
The possible score range is from 0 to 37, from which 17 or lower score indicating as moderate to severe cognitive impairment of children.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Bashir, Riphah International University
Publications and helpful links
General Publications
- Langlois JA, Rutland-Brown W, Wald MM. The epidemiology and impact of traumatic brain injury: a brief overview. J Head Trauma Rehabil. 2006 Sep-Oct;21(5):375-8. doi: 10.1097/00001199-200609000-00001.
- McCrea M, Guskiewicz KM, Marshall SW, Barr W, Randolph C, Cantu RC, Onate JA, Yang J, Kelly JP. Acute effects and recovery time following concussion in collegiate football players: the NCAA Concussion Study. JAMA. 2003 Nov 19;290(19):2556-63. doi: 10.1001/jama.290.19.2556.
- Hoffer ME, Gottshall KR, Moore R, Balough BJ, Wester D. Characterizing and treating dizziness after mild head trauma. Otol Neurotol. 2004 Mar;25(2):135-8. doi: 10.1097/00129492-200403000-00009.
- Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
- Bell DR, Guskiewicz KM, Clark MA, Padua DA. Systematic review of the balance error scoring system. Sports Health. 2011 May;3(3):287-95. doi: 10.1177/1941738111403122.
- Arliani GG, Astur DC, Yamada RK, Yamada AF, da Rocha Correa Fernandes A, Ejnisman B, de Castro Pochini A, Cohen M. Professional football can be considered a healthy sport? Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3907-3911. doi: 10.1007/s00167-015-3636-2. Epub 2015 May 17.
- Gurr B, Moffat N. Psychological consequences of vertigo and the effectiveness of vestibular rehabilitation for brain injury patients. Brain Inj. 2001 May;15(5):387-400. doi: 10.1080/02699050010005904.
- Murray DA, Meldrum D, Lennon O. Can vestibular rehabilitation exercises help patients with concussion? A systematic review of efficacy, prescription and progression patterns. Br J Sports Med. 2017 Mar;51(5):442-451. doi: 10.1136/bjsports-2016-096081. Epub 2016 Sep 21.
- Balatsouras DG, Koukoutsis G, Aspris A, Fassolis A, Moukos A, Economou NC, Katotomichelakis M. Benign Paroxysmal Positional Vertigo Secondary to Mild Head Trauma. Ann Otol Rhinol Laryngol. 2017 Jan;126(1):54-60. doi: 10.1177/0003489416674961. Epub 2016 Oct 25.
- O'Connor KL, Rowson S, Duma SM, Broglio SP. Head-Impact-Measurement Devices: A Systematic Review. J Athl Train. 2017 Mar;52(3):206-227. doi: 10.4085/1062-6050.52.2.05.
- Clark MD, Asken BM, Marshall SW, Guskiewicz KM. Descriptive Characteristics of Concussions in National Football League Games, 2010-2011 to 2013-2014. Am J Sports Med. 2017 Mar;45(4):929-936. doi: 10.1177/0363546516677793. Epub 2017 Jan 5.
- Broglio SP, Collins MW, Williams RM, Mucha A, Kontos AP. Current and emerging rehabilitation for concussion: a review of the evidence. Clin Sports Med. 2015 Apr;34(2):213-31. doi: 10.1016/j.csm.2014.12.005. Epub 2015 Jan 24.
- Gasquoine PG. Historical perspectives on evolving operational definitions of concussive brain injury: From railway spine to sport-related concussion. Clin Neuropsychol. 2020 Feb;34(2):278-295. doi: 10.1080/13854046.2019.1621383. Epub 2019 May 31.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01363 Ayesha Tabassum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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