Spastic Cerebral PalsyNCT05322759
Halliwick and Aquatic Exercises in Spastic Cerebral Palsy
A study testing aquatic exercises and halliwick exercise programme in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to find and compare the effects of halliwick exercises and aquatic exercises on gross motor function, trunk stability and hand function in spastic cerebral palsy. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- aquatic exercises and halliwick exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2021to 15 Dec 2021
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Both genders Male \& female
- Age 13-16 years
- Able to use assistive devices
- Diagnosed CP children
- Able to follow verbal commands
Who cannot join
- Unstable seizures
- had a surgery for the last 12 months or receive medication for spasticity
- Associated cognitive issue
- Incontinence
- Persistent infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Halliwick Exercises and Aquatic Excercices on Gross Motor Function, Trunk Stability and Hand Function in Spastic CP
The aim of this research is to find and compare the effects of halliwick exercises and aquatic exercises on gross motor function, trunk stability and hand function in spastic cerebral palsy.
Read the detailed description
Randomized controlled trials done at Dream Child institute and Children hospital complex Multan. The sample size was 32. The subjects were divided in two groups, 16 subjects in halliwick exercise group and 20 in aquatic exercise group. Study duration was of 6 months. Sampling technique applied was convenient non probability sampling technique. Only 13-16 years diagnosed spastic cerebral pals individuals were included. Tools used in the study are Gross motor function measure (GMFM-66), Trunk impairment scale (TIS) and Nine-hole peg test (NHPT). Data was being analyzed through SPSS 22.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- aquatic exercises, halliwick exercise programme
- Keywords
- Halliwick exercises, Aquatic exercises, Gross Motor Function measurment, Trunk control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aquatic exercisesOther
aquatic polymetric exercises for 30 min including hip abduction/adduction, knee flexion/extension, hip flexion/extension, holding pool from sides, bending forward and picking up objects, shoulder flexion/extension kangroo jumpes, jumping to sides.
halliwick exercise programmeOther
Halliwick exercise programme for 30 min include sagittal rotations, transversal rotations, longitudnal rotations and combined rotations.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercises | Active comparator | this group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min, that will include walking in shallow water and stretchings of upper and lower extremities. After that APE for 30 min followed cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions. Receives: Other: aquatic exercises; Other: halliwick exercise programme |
| Halliwick exercise programme | Experimental | this group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min that specifically includes mental adjustments along with walking in shallow side of pool and static stretchings. After that Halliwick exercise programme for 30 min that followed by cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions. Receives: Other: aquatic exercises; Other: halliwick exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM-88
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
Measured: first reading at 0 week
GMFM-88
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
Measured: final reading at 8 week
Trunk Impairment Scale
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
Measured: First reading at 0 week
Trunk Impairment Scale
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
Measured: Final reading at 8 week
Nine Hole Peg Test
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
Measured: first reading at 0 week
Nine Hole Peg Test
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
Measured: final reading at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start15 Feb 2021
- Primary completion15 Oct 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binash Afzal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322759
- Sponsor's protocol ID
- RiphahIU Nimra Arif
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2022
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurpinar B, Kara B, Idiman E. Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):249-255.
PubMed 32481240Akinola BI, Gbiri CA, Odebiyi DO. Effect of a 10-Week Aquatic Exercise Training Program on Gross Motor Function in Children With Spastic Cerebral Palsy. Glob Pediatr Health. 2019 Jun 25;6:2333794X19857378. doi: 10.1177/2333794X19857378. eCollection 2019.
PubMed 31263742Adar S, Dundar U, Demirdal US, Ulasli AM, Toktas H, Solak O. The effect of aquatic exercise on spasticity, quality of life, and motor function in cerebral palsy. Turk J Phys Med Rehabil. 2017 Aug 14;63(3):239-248. doi: 10.5606/tftrd.2017.280. eCollection 2017 Jun.
PubMed 31453460Ballington SJ, Naidoo R. The carry-over effect of an aquatic-based intervention in children with cerebral palsy. Afr J Disabil. 2018 Oct 29;7(0):361. doi: 10.4102/ajod.v7i0.361. eCollection 2018.
PubMed 30473998Terrens AF, Soh SE, Morgan P. The safety and feasibility of a Halliwick style of aquatic physiotherapy for falls and balance dysfunction in people with Parkinson's Disease: A single blind pilot trial. PLoS One. 2020 Jul 30;15(7):e0236391. doi: 10.1371/journal.pone.0236391. eCollection 2020.
PubMed 32730325Veldema J, Jansen P. Aquatic therapy in stroke rehabilitation: systematic review and meta-analysis. Acta Neurol Scand. 2021 Mar;143(3):221-241. doi: 10.1111/ane.13371. Epub 2020 Nov 22.
PubMed 33141446Carayannopoulos AG, Han A, Burdenko IN. The benefits of combining water and land-based therapy. J Exerc Rehabil. 2020 Feb 26;16(1):20-26. doi: 10.12965/jer.1938742.371. eCollection 2020 Feb.
PubMed 32161731Perez-de la Cruz S. Effect of an Aquatic Balance-Training Program in Patients with Chronic Stroke: A Single-Group Experimental Pilot Study. Medicina (Kaunas). 2020 Nov 28;56(12):656. doi: 10.3390/medicina56120656.
PubMed 33260785
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Halliwick Exercises and Aquatic Excercices on Gross Motor Function, Trunk Stability and Hand Function in Spastic CP
- ClinicalTrials.gov ID
- NCT05322759
- Acronym / sponsor ID
- RiphahIU Nimra Arif
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Halliwick exercises, Aquatic exercises, Gross Motor Function measurment, Trunk control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 12 Apr 2022 (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.
The aim of this research is to find and compare the effects of halliwick exercises and aquatic exercises on gross motor function, trunk stability and hand function in spastic cerebral palsy.
Detailed description
Randomized controlled trials done at Dream Child institute and Children hospital complex Multan. The sample size was 32. The subjects were divided in two groups, 16 subjects in halliwick exercise group and 20 in aquatic exercise group. Study duration was of 6 months. Sampling technique applied was convenient non probability sampling technique. Only 13-16 years diagnosed spastic cerebral pals individuals were included. Tools used in the study are Gross motor function measure (GMFM-66), Trunk impairment scale (TIS) and Nine-hole peg test (NHPT). Data was being analyzed through SPSS 22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercises | Active comparator | Other: aquatic exercises, Other: halliwick exercise programmethis group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min, that will include walking in shallow water and stretchings of upper and lower extremities. After that APE for 30 min followed cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions. |
| Halliwick exercise programme | Experimental | Other: aquatic exercises, Other: halliwick exercise programmethis group receives sessions for consecutive 8 weeks and 3 days per week. warm up for 10 min that specifically includes mental adjustments along with walking in shallow side of pool and static stretchings. After that Halliwick exercise programme for 30 min that followed by cool down period for 5 min. exercise frequency is 3 sets of each exercise with 15 repetitions. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both genders Male \& female
- Age 13-16 years
- Able to use assistive devices
- Diagnosed CP children
- Able to follow verbal commands
Key exclusion criteria (5 listed)
- Unstable seizures
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 |
|---|---|---|
| aquatic exercisesaquatic polymetric exercises for 30 min including hip abduction/adduction, knee flexion/extension, hip flexion/extension, holding pool from sides, bending forward and picking up objects, shoulder flexion/extension kangroo jumpes, jumping to sides. | Other | Aquatic exercises, Halliwick exercise programme |
| halliwick exercise programmeHalliwick exercise programme for 30 min include sagittal rotations, transversal rotations, longitudnal rotations and combined rotations. | Other | Aquatic exercises, Halliwick exercise programme |
Primary outcome
GMFM-88
Time frame: first reading at 0 week
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
GMFM-88
Time frame: final reading at 8 week
It is an observational clinical measure designed to evaluate gross motor function in children with cerebral palsy.
Trunk Impairment Scale
Time frame: First reading at 0 week
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
Trunk Impairment Scale
Time frame: Final reading at 8 week
this scale measures static sitting and dynamic balance as well as trunk co-ordination. this aims to score the quality of trunk movement and to be as a guide for treatment.
Nine Hole Peg Test
Time frame: first reading at 0 week
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
Nine Hole Peg Test
Time frame: final reading at 8 week
it is a standerized test for measuring hand function and finger dexterity. scoring is done on the basis of average time for consecutive 4 trial with dominant hand and then by non-dominant hand.
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 12 Apr 2022.
- Background: PubMed 32481240Gurpinar B, Kara B, Idiman E. Effects of aquatic exercises on postural control and hand function in Multiple Sclerosis: Halliwick versus Aquatic Plyometric Exercises: a randomised trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):249-255.
- Background: PubMed 31263742Akinola BI, Gbiri CA, Odebiyi DO. Effect of a 10-Week Aquatic Exercise Training Program on Gross Motor Function in Children With Spastic Cerebral Palsy. Glob Pediatr Health. 2019 Jun 25;6:2333794X19857378. doi: 10.1177/2333794X19857378. eCollection 2019.
- Background: PubMed 31453460Adar S, Dundar U, Demirdal US, Ulasli AM, Toktas H, Solak O. The effect of aquatic exercise on spasticity, quality of life, and motor function in cerebral palsy. Turk J Phys Med Rehabil. 2017 Aug 14;63(3):239-248. doi: 10.5606/tftrd.2017.280. eCollection 2017 Jun.
- Background: PubMed 30473998Ballington SJ, Naidoo R. The carry-over effect of an aquatic-based intervention in children with cerebral palsy. Afr J Disabil. 2018 Oct 29;7(0):361. doi: 10.4102/ajod.v7i0.361. eCollection 2018.
- Background: PubMed 32730325Terrens AF, Soh SE, Morgan P. The safety and feasibility of a Halliwick style of aquatic physiotherapy for falls and balance dysfunction in people with Parkinson's Disease: A single blind pilot trial. PLoS One. 2020 Jul 30;15(7):e0236391. doi: 10.1371/journal.pone.0236391. eCollection 2020.
- Background: PubMed 33141446Veldema J, Jansen P. Aquatic therapy in stroke rehabilitation: systematic review and meta-analysis. Acta Neurol Scand. 2021 Mar;143(3):221-241. doi: 10.1111/ane.13371. Epub 2020 Nov 22.
- Background: PubMed 32161731Carayannopoulos AG, Han A, Burdenko IN. The benefits of combining water and land-based therapy. J Exerc Rehabil. 2020 Feb 26;16(1):20-26. doi: 10.12965/jer.1938742.371. eCollection 2020 Feb.
- Background: PubMed 33260785Perez-de la Cruz S. Effect of an Aquatic Balance-Training Program in Patients with Chronic Stroke: A Single-Group Experimental Pilot Study. Medicina (Kaunas). 2020 Nov 28;56(12):656. doi: 10.3390/medicina56120656.
- 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.
Binash Afzal, Phd* 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 aquatic exercises and halliwick exercise programme in people with Spastic 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 5 inclusion and 5 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 12 Apr 2022. 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?
GMFM-88 (time frame: first reading at 0 week). The study lists 6 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 NCT05322759, which also lists 8 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 12 Apr 2022.