Cerebral PalsyNCT05775315

Additional Effect of Visual Feedback Along With AOT on Balance,Mobility and Cognition in CP

A study testing Action Observation Therapy and Action Observation Therapy along with visual feedback in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

the study aims to find the effectiveness of visual feedback along with action observation therapy in cerebral palsy. the effect of AOT on mobility, cognition and balance of the targeted population will be the intrest of the researcher Read more about this study

Who is it for?: Ages 5 to 15 years
Conditions the study is for: Cerebral Palsy
What is being tested?: Action Observation Therapy and Action Observation Therapy along with visual feedback
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 sitePakistan
Study dates: 16 Sep 2022to 1 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

Unable to walk
Children with severe co-morbidities

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Center for Profound Education Trust
Rawalpindi, Punjab Province, 46000

Other trials in Pakistan

About this study

Official title: Additional Effects of Visual Feedback Along With Action Observation Therapy on Balance, Mobility and Cognition in Cerebral Palsy

Conditions: Cerebral Palsy
Being tested: Action Observation Therapy, Action Observation Therapy along with visual feedback
Keywords: action observation therapy, cerebral palsy, visual feedback
Medical subject headings: Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Action Observation TherapyOther
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.
Action Observation Therapy along with visual feedbackOther
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.

Study groups in NCT05775315
Study group	Role	What they receive
Action Observation Therapy	Experimental	exercises of AO protocol Receives: Other: Action Observation Therapy
Visual feedback and Action Observation Therapy	Active comparator	Excercises of AO protocol infront of a mirror Receives: Other: Action Observation Therapy along with visual feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

Gross Motor Function Classification Scale (GMFCS)
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.
Measured: 12 weeks
Pediatric Balance Scale (PBS)
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.
Measured: 12 weeks
Timed 10-meter walk test
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).
Measured: 12 weeks
Mini Mental State Exam
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20221 Jul 2023

First posted20 Mar 2023
Study start16 Sep 2022
Primary completion1 Jul 2023
Study completion1 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Cerebral PalsyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05775315
Sponsor's protocol ID: REC/01363 Ayesha Tabassum
Status last verified: Jul 2023
First submitted: 7 Mar 2023
Last updated: 1 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 25982623
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.
PubMed 23016020
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.
PubMed 15021772
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.
PubMed 11350653
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.
PubMed 27655831
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.
PubMed 27780909
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.
PubMed 14625332
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.
PubMed 20588094
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.
PubMed 16983222
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.
PubMed 28387553
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.
PubMed 28056179
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.
PubMed 25818710
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.
PubMed 31146639

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Additional Effects of Visual Feedback Along With Action Observation Therapy on Balance, Mobility and Cognition in Cerebral Palsy
ClinicalTrials.gov ID: NCT05775315
Acronym / sponsor ID: REC/01363 Ayesha Tabassum
Conditions: Cerebral Palsy
Keywords: action observation therapy, cerebral palsy, visual feedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Riphah International UniversityUniversity, hospital or other
Study start: 16 Sep 2022 (actual)
Primary completion: 1 Jul 2023 (actual)
Study completion: 1 Jul 2023 (actual)
First posted: 20 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Action Observation Therapy	Experimental	Other: Action Observation Therapyexercises of AO protocol
Visual feedback and Action Observation Therapy	Active comparator	Other: Action Observation Therapy along with visual feedbackExcercises of AO protocol infront of a mirror

Who may qualify

Ages: 5 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

Unable to walk
Children with severe co-morbidities

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Action Observation TherapyExercises 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.	Other	Action Observation Therapy
Action Observation Therapy along with visual feedbackExercises 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.	Other	Visual feedback and Action Observation Therapy

Primary outcome

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.
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.
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).
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Background: PubMed 25982623Arliani 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.
Background: PubMed 23016020Bell 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.
Background: PubMed 15021772Hoffer 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.
Background: PubMed 11350653Gurr 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.
Background: PubMed 27655831Murray 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.
Background: PubMed 27780909Balatsouras 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.
Background: PubMed 14625332McCrea 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.
Background: PubMed 20588094Alsalaheen 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.
Background: PubMed 16983222Langlois 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.
Background: PubMed 28387553O'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.
Background: PubMed 28056179Clark 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.
Background: PubMed 25818710Broglio 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ayesha Bashir principal investigator

Riphah International University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Action Observation Therapy and Action Observation Therapy along with visual feedback in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Classification Scale (GMFCS) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05775315, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.