Balance ProblemsEarly Phase 1NCT02842398
Independent Walking Speed and Crossing a City Street
A Early Phase 1 study testing Balance Master and Customary Care in people with Balance Problems and Cerebral Palsy, run by Blythedale Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within… Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Balance Problems, Cerebral Palsy
- What is being tested?
- Balance Master and Customary Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jan 2016
- Phase
- Early Phase 1
- 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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses.
- Receiving physical therapy services that include ambulation training.
Who cannot join
- Diagnosis of a progressive disorder.
- Inability to follow directions.
- Uncorrected vision impairment.
- Require additional physical assistance to ascend a ramp and over force plate.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Blythedale Children's Hospital
Valhalla, New York, 10595
About this study
The purpose of this study is to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec).
Read the detailed description
The ability to adequately perform functional tasks at a level that allows independent community living is key to measuring the success of any physical therapy program. The essential tasks needed to allow independent community living have been well documented in the elderly population. However, these tasks have not been delineated in the pediatric population. The investigators aim to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec). One essential task that is necessary in the urban environment is to have the ability to cross a street within the time constraint of a traffic signal. Walking speed becomes increasingly important for those living in urban settings, as the ability to cross the street safely is fundamental for achieving independence. One of the major criticisms of clinic/lab-based measures of gait speed is that relative performance may not be representative of independence within the community. Participants aged 5 to 21 years, will be recruited from the patient population at Blythedale Children's Hospital for a six week trial. Children will be assigned to one of two random groups: one weekly Balance Master sequence training group (in addition to their regularly scheduled therapy sessions) and a group that continue regularly scheduled therapy sessions alone. Gait velocity will be measured by "Walk Across" Functional Assessment using Balance Master long force plate.
- Conditions
- Balance Problems, Cerebral Palsy
- Being tested
- Balance Master, Customary Care
- Keywords
- gait, balance, street-crossing
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance MasterBehavioural
Customary CareBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Balance Master Training | Experimental | Children receive one weekly Balance Master training session, in addition to their weekly physical therapy sessions. During Balance Master training, children practice balance on a Balance Master device that simulates crossing a city street. Receives: Behavioral: Balance Master |
| Customary Care | Active comparator | Children received their customary scheduled physical therapy sessions, without Balance Master training Receives: Behavioral: Customary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gait velocity after intervention
Measure gait velocity as participant walks across a force plate on the floor
Measured: measured at day 1 of intervention and end of week 6 of intervention
Secondary outcomes (1)
Weight
Body weight on a digital scale
Measured: Day 1 of Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance ProblemsStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blythedale Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842398
- Sponsor's protocol ID
- Balance_Master
- Status last verified
- May 2018
- First submitted
- 18 Jul 2016
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independent Walking Speed and Crossing a City Street
- ClinicalTrials.gov ID
- NCT02842398
- Acronym / sponsor ID
- Balance_Master
- Conditions
- Balance Problems, Cerebral Palsy
- Keywords
- gait, balance, street-crossing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Blythedale Children's HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jul 2016 (estimated)
- 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 purpose of this study is to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving inpatient or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec).
Detailed description
The ability to adequately perform functional tasks at a level that allows independent community living is key to measuring the success of any physical therapy program. The essential tasks needed to allow independent community living have been well documented in the elderly population. However, these tasks have not been delineated in the pediatric population. The investigators aim to determine if selected sequence training using the Balance Master, added to established physical therapy treatment programs, will increase gait velocity of ambulatory children receiving in-or outpatient rehabilitation in relation to their ability to cross an intersection within the confines of community traffic signal (>120 cm/sec). One essential task that is necessary in the urban environment is to have the ability to cross a street within the time constraint of a traffic signal. Walking speed becomes increasingly important for those living in urban settings, as the ability to cross the street safely is fundamental for achieving independence. One of the major criticisms of clinic/lab-based measures of gait speed is that relative performance may not be representative of independence within the community. Participants aged 5 to 21 years, will be recruited from the patient population at Blythedale Children's Hospital for a six week trial. Children will be assigned to one of two random groups: one weekly Balance Master sequence training group (in addition to their regularly scheduled therapy sessions) and a group that continue regularly scheduled therapy sessions alone. Gait velocity will be measured by "Walk Across" Functional Assessment using Balance Master long force plate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance Master Training | Experimental | Behavioral: Balance MasterChildren receive one weekly Balance Master training session, in addition to their weekly physical therapy sessions. During Balance Master training, children practice balance on a Balance Master device that simulates crossing a city street. |
| Customary Care | Active comparator | Behavioral: Customary CareChildren received their customary scheduled physical therapy sessions, without Balance Master training |
Who may qualify
- Ages
- 5 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ability to ambulate independently at least 25 feet with or without assistance device and/or orthoses.
- Receiving physical therapy services that include ambulation training.
Key exclusion criteria (5 listed)
- Diagnosis of a progressive disorder.
- Inability to follow directions.
- Uncorrected vision impairment.
- Require additional physical assistance to ascend a ramp and over force plate.
- Refusal to participate.
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 |
|---|---|---|
| Balance Master | Behavioural | Balance Master Training |
| Customary Care | Behavioural | Customary Care |
Primary outcome
Change in gait velocity after intervention
Time frame: measured at day 1 of intervention and end of week 6 of intervention
Measure gait velocity as participant walks across a force plate on the floor
1 secondary outcome
Weight
Time frame: Day 1 of Intervention
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 18 May 2018.
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Dual-Task Balance and Gait Training Combined With Cognitive Training in Parkinson's Patients
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Balance Master and Customary Care in people with Balance Problems and Cerebral Palsy, run by Blythedale Children's Hospital at 1 site in United States.
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 2 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 18 May 2018. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 gait velocity after intervention (time frame: measured at day 1 of intervention and end of week 6 of intervention). 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 18 May 2018.