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| ID | Type | Description | Link |
|---|---|---|---|
| Yad Hanadiv 5106 | Other Grant/Funding Number | Yad Hanadiv Foundation; CPIRF |
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The overall objective is to improve the functional status of Middle East adolescents with disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied research project.
Specific objectives are:
To compare the efficacy of two rehabilitation technologies to facilitate neural reorganization, transfer and retention of treatments results to improve walking in real life situations The investigators suggest a new approach of treatment intervention that will induce unexpected changes of underfoot slopes during walking and will force the central nervous system (CNS) to react and solve problems.
The investigators also propose that the new approach will have a significantly superior motor function improvement that will be transferred to real environmental settings and be retained for long periods of time.
Research methods and materials
Subjects:
A total of 166 subjects will be studied in two groups of handicapped persons:
Each group will be sub-divided into three secondary groups, having similar age distributions and level of motor function for the two different therapy approaches:
The time flow protocol:
Recruiting subjects according to inclusion/exclusion criteria
The subjects will be tested with the following measures (see arms)at
The treatments will start in a week from T0 The T1 will be performed in a week after the treatment was completed The T2 will be performed 6 months (take or leave 2 weeks) after T1, 6 months after treatment was stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Re-Step | Experimental | Mechatronic shoe with a sole made to change slopes in the swing phase of walking. This unpredictable change will introduce a situation of necessary adaptation to keep balance |
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| Dummy shoes | Experimental | The shoes are in the same shape and weight of the Re-Step without the perturbations. |
|
| treadmill | Active Comparator | A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chaotic Perturbation | Device | Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the random shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will impose perturbations in the range tolerated by the subject. The therapist will make a written report of each session. |
| Measure | Description | Time Frame |
|---|---|---|
| 10 meter walk test (10MWT) | 10-meter walk test (Rossier & Wade, 2001) will assess normal walking speed. The participant walks a straight path distance of 10 meters at normal walking speed with time recorded. The test will be performed twice with the number of steps counted. The tester or an assistant remains near the participant to prevent a fall or injury if they appear unsteady. |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minuets Walk Test (6MinWT) | The 6-minute walk test (Enright, 2003) will be used to assess walking endurance. Subjects are instructed to cover as much distance as possible while walking around a marked course for 6 minutes. A member of the research staff will closely monitor the subjects. | |
| Mechanical Efficiency |
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Inclusion Criteria:
Inclusion criteria for CP group:
Exclusion criteria for CP group:
Inclusion Criteria:
Inclusion criteria for HP group:
Exclusion Criteria:
Exclusion criteria for HP group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simona Bar-Haim, PhD | Contact | +972 8 9778280 | adi-star@013.net | |
| Netta Harries, BPT | Contact | +972 8 9778280 | netaa@asaf.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Eli Lahat, MD Proffesor | Assaf-Harofeh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Recruiting | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25113573 | Derived | Harries N, Loeppky JA, Shaheen S, Al-Jarrah M, Molteni F, Hutzler Y, Bar-Haim S; MESF Project. A stair-climbing test for measuring mechanical efficiency of ambulation in adults with chronic stroke. Disabil Rehabil. 2015;37(11):1004-8. doi: 10.3109/09638288.2014.948131. Epub 2014 Aug 12. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 20, 2018 | |
| Unrelease | May 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 20, 2018 | May 15, 2018 |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
| Dummy not active shoes | Device | Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the dummy shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will not impose perturbations. The therapist will make a written report of each session. |
|
|
| Treadmill training | Device | Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will exercise basic stretching and muscle strengthening, then walk on the treadmill. A physiotherapist according the subject's rate of improvement will determine the increase in treadmill velocity and slope. The therapist will make a written report after each session. |
|
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Mechanical efficiency will be measured by the stair-climbing test (SCT) (Bar-Haim, et al. 2004; 2008). Metabolic cost is predicted from heart rate during the external work while stair-climbing and mechanical efficiency is calculated. |
| WHOQOL-BREF | The WHO's Quality of Life (WHOQoL-BREF) is an international cross-culturally comparable quality of life assessment instrument. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns. |
| Berg Balance Scale (BBS) | The BBS is a 14-item scale that quantitatively assesses balance and risk for falls in older community-dwelling adults through direct observation of their performance. |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D008919 | Investigative Techniques |