Spastic DiplegiaNCT03166293
Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia
A study testing Intensive leg training with a physical therapist in people with Spastic Diplegia, run by University of Alberta at 2 sites in Canada.
Trial summary
This is a randomized controlled trial comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of motor function in the legs in young children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 8 to 36 months
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- Intensive leg training with a physical therapist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2017to 3 Nov 2020
- 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 8 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 8 mo - 3 yr old
- Evidence of periventricular white matter injury on diagnostic imaging
- clinical evidence of spastic diplegia
Who cannot join
- born before gestational age of 25 weeks
- birth weight <1000g (to exclude confounds related to extreme prematurity and low birth weights)
- MRI evidence of diffuse injury to the cerebral or cerebellar cortex
- uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
- cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
- Botulinum toxin (BTX-A) injections in the last 6 months
- Predicted GMFCS 4 or 5
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta
University of Alberta
Edmonton, Alberta, T6G 2G4
About this study
Official title: Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia From Encephalopathy of Prematurity
This is a randomized controlled trial comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of motor function in the legs in young children with spastic diplegia.
Read the detailed description
Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.
- Conditions
- Spastic Diplegia
- Being tested
- Intensive leg training with a physical therapist
- Keywords
- Cerebral Palsy, Physical Therapy, Rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive leg training with a physical therapistBehavioural
Also called Therapist training
Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. A physical therapist will supervise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Group | Experimental | Children will participate in intensive leg training with a physical therapist 1 hour/day, 4 days/week for 12 weeks. Children will continue to receive standard physical therapy care. Children will be followed for one year from the time of enrollment in the study. Receives: Behavioral: Intensive leg training with a physical therapist |
| Delay Group | Experimental | Children will be monitored for 3 months with no intervention. Children will participate in intensive leg training with a physical therapist after the 3 month delay period. Training will be 1 hour/day, 4 days/week for 12 weeks. They will continue to receive standard care throughout. Children will be followed for one year from the time of enrollment in the study. Receives: Behavioral: Intensive leg training with a physical therapist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months
This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.
Measured: Baseline, 3 months
Secondary outcomes (1)
Change in forces during treadmill walking over 3 months
The child will be supported to walk on a treadmill while we record the leg motions and the forces under the feet during walking.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jun 2017
- Primary completion4 Jan 2019
- Study completion3 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies 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
- Model description
- Participants will be randomly assigned to receive 3 months of intervention or 3 months of observation. Participants in the observation group will be offered the intervention once the observation period is complete
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaynie Yang, PhD, Principal investigator, University of AlbertaMonica Gorassini, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166293
- Sponsor's protocol ID
- Pro00072587
- Status last verified
- Nov 2020
- First submitted
- 23 May 2017
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intensive Exercise to Improve Walking in Children With Spastic Diplegia From Encephalopathy of Prematurity
- ClinicalTrials.gov ID
- NCT03166293
- Acronym / sponsor ID
- Pro00072587
- Conditions
- Spastic Diplegia
- Keywords
- Cerebral Palsy, Physical Therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 3 Nov 2020 (actual)
- First posted
- 25 May 2017 (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.
This is a randomized controlled trial comparing 3 months of intensive leg exercise to standard physiotherapy care for the improvement of motor function in the legs in young children with spastic diplegia.
Detailed description
Children born prematurely are at risk of brain injury that can result in cerebral palsy(CP), most often affecting the legs, called spastic diplegia. Current treatment is largely passive, including leg braces, repeated injection of a paralyzing agent (Botox) in muscles that are abnormally active, and surgery as deformities occur. Active, physical therapy for weak muscles is infrequent, occurring twice a month or less. Yet, recent work with mammals show that early brain injury can be alleviated by intensive exercise therapy, but only while the animal is very young. Building on the success with early, intensive therapy for children with perinatal (around birth) stroke, the investigators will apply intensive therapy for the legs in children with diplegia. Children (8 mo - 3 yr old) will be randomly assigned to start treatment immediately or delay treatment for 3 mo. The delay period controls for improvement without treatment. These children will also receive treatment after the delay period. The therapy will be guided by physical therapists, and similar to the project on perinatal stroke. Children who live beyond commuting distance from the centres will form a 3rd group, whose parents will be coached by therapists to train the child at home. This group will show whether parents can be as effective as a therapist. Finally, when all children turn 4 yr old, they will be compared to other 4-yr-old children with the same diagnosis, but no training, to determine if there are long term benefits. The investigators anticipate that like the children with perinatal stroke, early intensive exercise will improve mobility, facilitate earlier and better walking, and that the effects will be enduring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to receive 3 months of intervention or 3 months of observation. Participants in the observation group will be offered the intervention once the observation period is complete
| Arm | Type | Receives |
|---|---|---|
| Immediate Group | Experimental | Behavioral: Intensive leg training with a physical therapistChildren will participate in intensive leg training with a physical therapist 1 hour/day, 4 days/week for 12 weeks. Children will continue to receive standard physical therapy care. Children will be followed for one year from the time of enrollment in the study. |
| Delay Group | Experimental | Behavioral: Intensive leg training with a physical therapistChildren will be monitored for 3 months with no intervention. Children will participate in intensive leg training with a physical therapist after the 3 month delay period. Training will be 1 hour/day, 4 days/week for 12 weeks. They will continue to receive standard care throughout. Children will be followed for one year from the time of enrollment in the study. |
Who may qualify
- Ages
- 8 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 8 mo - 3 yr old
- Evidence of periventricular white matter injury on diagnostic imaging
- clinical evidence of spastic diplegia
Key exclusion criteria (7 listed)
- born before gestational age of 25 weeks
- birth weight <1000g (to exclude confounds related to extreme prematurity and low birth weights)
- MRI evidence of diffuse injury to the cerebral or cerebellar cortex
- uncontrolled epilepsy or infantile spasms in the past 6 months (contraindication for TMS)
- cardiovascular or musculoskeletal complications that preclude participation in intensive exercise
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 |
|---|---|---|
| Intensive leg training with a physical therapistAlso: Therapist trainingIntensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. A physical therapist will supervise sessions. | Behavioural | Delay Group, Immediate Group |
Primary outcome
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months
Time frame: Baseline, 3 months
This is a 66 item criterion-referenced observational measure to assess change in gross motor function of children with cerebral palsy.
1 secondary outcome
Change in forces during treadmill walking over 3 months
Time frame: Baseline, 3 months
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 5 Nov 2020.
- 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.
Jaynie Yang, PhD principal investigator
University of Alberta
Monica Gorassini, PhD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive leg training with a physical therapist in people with Spastic Diplegia, run by University of Alberta at 2 sites in Canada.
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 3 inclusion and 7 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 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change in Gross Motor Functional Measure - 66 Items (GMFM-66) over 3 months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.