StrokeNCT00489580
A Pilot Study Investigating the Feasibility of the Saebo Arm Training Program on an Inpatient Population
A study testing SaeboFlex Dynamic Hand Orthosis and Saebo F.T.M. Arm Training Program in people with Stroke and Hemiplegia, run by Kessler Foundation at 1 site in United States.
Trial summary
Study Objectives: 1. To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population. 2. To compare functional improvements in hand and UE use achieved with the F.T.M. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- SaeboFlex Dynamic Hand Orthosis and Saebo F.T.M. Arm Training Program
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to May 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- Must be seen within three full working days of admission for screening
- Alert and Oriented to person and place with the ability to complete at a minimum a one step verbal command,
- Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension
- 1/4 range of volitional finger flexion when the affected hand is passively positioned in a minimum of 15degrees of wrist extension with the MCP's at neutral and PIP's / DIP's in extension
- Patient must be independent with seated posture in a chair with a firm seat and back support but no arm rests
- Patient can maintain independent seated balance when unaffected upper extremity is fully outstretched in any direction
- Admitted to inpatient stroke rehabilitation at Kessler Institute
Who cannot join
- Inpatient physician unwilling to clear patient to participate
- Medically unsuitable for therapeutic intervention,
- Using the affected hand and arm, able to volitionally grasp and release a racquet ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
- Flaccidity in the affected UE or hand
- Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
- Hx of rheumatoid arthritis, carpal tunnel syndrome or other hand neuropathy
- Moderate to severe weeping or pitting edema
- No previous stroke prior to the one prompting admission
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Institute for Rehabilitation
East Orange, New Jersey, 07018
About this study
Official title: A Pilot Study Investigating the Feasibility of Using a Functional Tone Management (F.T.M.) Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population
Study Objectives:
- To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.
- To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
- To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
- To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.
Read the detailed description
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the past two years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population. During that time, two factors, other than the severity of the initial injury, were identified as having a significant affect on the outcomes achieved in treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the proper treatment dosage and treatment protocol for the application of the F.T.M. Program to the inpatient post stroke rehabilitation population. Additionally, information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol.
- Conditions
- Stroke, Hemiplegia
- Being tested
- SaeboFlex Dynamic Hand Orthosis, Saebo F.T.M. Arm Training Program
- Keywords
- stroke, weakness, motor recovery
- Medical subject headings
- Stroke, Hemiplegia, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaeboFlex Dynamic Hand OrthosisDevice
Saebo F.T.M. Arm Training ProgramProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength (measured using dynamometry)
Measured: At admission and at discharge
Secondary outcomes (7)
Length of Stay (days)
Measured: The duration of the subject's inpatient hospital stay.
Stroke Impact Scale Score
Measured: At admission and at discharge
Action Research Arm Test Score
Measured: At admission and at discharge
Ashworth Assessment (Upper Extremity) Scores
Measured: At admission and at discharge
Fugl-Meyer Assessment (Upper Extremity) Scores
Measured: At admission and at discharge
Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist)
Measured: At admission and at discharge
Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range)
Measured: At admission and at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startAug 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Saebo, Inc.
- Investigators
- Elie P Elovic, M.D., Principal investigator, Kessler Medical Rehabilitation Research & Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489580
- Sponsor's protocol ID
- E-519-05
- Status last verified
- Jul 2007
- First submitted
- 20 Jun 2007
- Last updated
- 25 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating the Feasibility of Using a Functional Tone Management (F.T.M.) Arm Training Program With the SaeboFlex Dynamic Hand Orthosis on an Inpatient Population
- ClinicalTrials.gov ID
- NCT00489580
- Acronym / sponsor ID
- E-519-05
- Conditions
- Stroke, Hemiplegia
- Keywords
- stroke, weakness, motor recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Saebo, Inc.
- Study start
- Aug 2005
- Study completion
- May 2006 (actual)
- First posted
- 21 Jun 2007 (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.
Study Objectives:
- To document the safe and effective application of the F.T.M. Arm Training Program using the SaeboFlex to an inpatient post stroke rehabilitation population.
- To compare functional improvements in hand and UE use achieved with the F.T.M. program as compared to generally applied therapeutic treatment approaches.
- To develop recommendations for an inpatient retraining protocol that could then be evaluated in a multi-center trial.
- To document the retention of UE and hand improvements after SaeboFlex training is discontinued as well as the carry over of these gains into daily function after therapy has been discontinued.
Detailed description
Therapeutic interventions for the recovery of hand function after a neurological injury have historically been very limited. A significant body of research now supports the use of an upper extremity retraining approach for functional recovery after neurological injury. Few therapeutic approaches offer any intervention specifically focused on grasp and release retraining. In an effort to address this deficit, the SaeboFlex dynamic hand orthosis was developed by occupational therapists. The F.T.M. Arm Training Program has been safely used by hundreds of occupational and physical therapists on over one thousand patients in outpatient neurological rehabilitation over the past two years. It is currently an accepted modality of treatment for the management of hand paresis in the acquired brain injury population. During that time, two factors, other than the severity of the initial injury, were identified as having a significant affect on the outcomes achieved in treatment. They are learned non-use and soft tissue shortening of the finger flexors. All treatment delivered to the subjects that partake in this study will be clinical care and the only research component of this study will be the assessment of outcomes. The purpose of this study is to explore the proper treatment dosage and treatment protocol for the application of the F.T.M. Program to the inpatient post stroke rehabilitation population. Additionally, information on functional outcome measures will be collected and compared to a matched control group that undergoes the standard therapeutic protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older,
- Must be seen within three full working days of admission for screening
- Alert and Oriented to person and place with the ability to complete at a minimum a one step verbal command,
- Demonstrated active range of motion of 10 degrees shoulder flexion / abduction and 10 degrees of elbow flexion / extension
- 1/4 range of volitional finger flexion when the affected hand is passively positioned in a minimum of 15degrees of wrist extension with the MCP's at neutral and PIP's / DIP's in extension
Key exclusion criteria (8 listed)
- Inpatient physician unwilling to clear patient to participate
- Medically unsuitable for therapeutic intervention,
- Using the affected hand and arm, able to volitionally grasp and release a racquet ball x10 at maximal volitional shoulder flexion with wrist extension of 10 degrees or more.
- Flaccidity in the affected UE or hand
- Fixed joint deformities, contractures or joint hypermobility that prevents proper joint positioning in the orthosis.
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 |
|---|---|---|
| SaeboFlex Dynamic Hand Orthosis | Device | – |
| Saebo F.T.M. Arm Training Program | Procedure or surgery | – |
Primary outcome
Hand grip strength (measured using dynamometry)
Time frame: At admission and at discharge
7 secondary outcomes
Length of Stay (days)
Time frame: The duration of the subject's inpatient hospital stay.
Stroke Impact Scale Score
Time frame: At admission and at discharge
Action Research Arm Test Score
Time frame: At admission and at discharge
Ashworth Assessment (Upper Extremity) Scores
Time frame: At admission and at discharge
Fugl-Meyer Assessment (Upper Extremity) Scores
Time frame: At admission and at discharge
Goniometric Range of Motion Evaluation, Passive and Active (Shoulder, Elbow, and Wrist)
Time frame: At admission and at discharge
Assessment of Active Range of Motion (Fingers, as ¼ range, ½ range, ¾ range or full range)
Time frame: At admission and at discharge
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 25 Jul 2007.
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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.
Elie P Elovic, M.D. principal investigator
Kessler Medical Rehabilitation Research & Education Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SaeboFlex Dynamic Hand Orthosis and Saebo F.T.M. Arm Training Program in people with Stroke and Hemiplegia, run by Kessler Foundation 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 8 inclusion and 8 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 25 Jul 2007. 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.
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?
Hand grip strength (measured using dynamometry) (time frame: At admission and at discharge). 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 25 Jul 2007.