Shoulder and elbow function of affected upper limbs of stroke patients Nervous System Diseases
Conditions
Interventions
Current intervention as of 18/06/2019:
Allocation and blinding:
Blinding in this study will be partial. The control group will be blinded from the treatment whereas bli
Sponsors
Xuzhou Rehabilitation Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/05/2019: 1. Aged 45 to 75 years 2. Diagnosis of stroke or cerebrovascular accident identified by a neurologist or medical doctor using appropriate diagnostic tools such as MRI scan, CT scan and other relevant tools 3. First time stroke 4. Brunnstrom’s stage 1 to 4 of the arm and hand 5. Registered at Xuzhou Rehabilitation Hospital 6. Participants should be co-operative and understand Chinese language Previous inclusion criteria as of 13/03/2019: 1. Aged 45 to 75 years 2. Diagnosis of stroke or cerebrovascular accident identified by a neurologist or medical doctor using appropriate diagnostic tools such as MRI scan, CT scan and other relevant tools 3. First stroke that occurred less than 2 months previously 4. Brunnstrom’s stage 1 and 2 of the arm and hand 5. Registered at Xuzhou Rehabilitation Hospital 6. Participants should be co-operative and understand Chinese language Previous inclusion criteria as of 18/01/2019: 1. Aged 40 to 75 years 2. Diagnosis of stroke or cerebrovascular accident identified by a neurologist or medical doctor using appropriate diagnostic tools such as MRI scan, CT scan and other relevant tools 3. First stroke that occurred less than 2 months previously 4. Brunnstrom’s stage 1 and 2 of the arm and hand 5. Registered at Xuzhou Rehabilitation Hospital 6. Participants should be co-operative and understand Chinese language Previous inclusion criteria: 1. Aged 30 to 90 years 2. Diagnosis of stroke or cerebrovascular accident identified by a neurologist or medical doctor using appropriate diagnostic tools such as MRI scan, CT scan and other relevant tools 3. First stroke that occurred less than 3 months previously 4. Brunnstrom’s stage 1 and 2 of the arm and hand 5. Registered at Xuzhou Rehabilitation Hospital 6. Participants should be co-operative and understand Chinese language
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/05/2019: 1. Not co-operative 2. Do not speak Chinese language 3. Unstable patients 4. Patient of other hospitals in the same city 5. History of peripheral nerve injuries 6. History of neurosurgical treatments 7. Soft tissue tightness and musculoskeletal deformities not as a result of stroke 8. Brunnstrom’s stages 5 and 6 of arm and hand 9. Comorbidities such as severe heart disease, liver disease, epilepsy, HIV infection, psychiatric problems, tuberculosis, infections or skin diseases 10. Patients who cannot speak or understand instructions Previous exclusion criteria as of 18/01/2019: 1. Not co-operative 2. Do not speak Chinese language 3. Unstable patients 4. Patient of other hospitals in the same city 5. History of peripheral nerve injuries 6. History of neurosurgical treatments 7. Soft tissue tightness and musculoskeletal deformities not as a result of stroke 8. Brunnstrom’s stages of 3, 4, 5 and 6 of arm and hand 9. Comorbidities such as severe heart disease, liver disease, epilepsy, HIV infection, psychiatric problems, tuberculosis, infections or skin diseases 10. Patients who cannot speak or understand instructions Previous exclusion criteria: 1. Not co-operative 2. Do not speak Chinese language 3. Unstable patients 4. Patient of other hospitals in the same city 5. History of peripheral nerve injuries 6. History of neurosurgical treatments 7. Soft tissue tightness and musculoskeletal deformities not as a result of stroke 8. Brunnstrom’s stages of 3, 4, 5 and 6 of arm and hand 9. Comorbidities such as severe heart disease, liver disease, epilepsy, HIV infection, psychiatric problems, tuberculosis, infections or skin diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 13/03/2019: Upper limb function assessed by the therapist using the Fugl-Meyer for Upper Extremity (FMA-UE) scale while patient is sitting down at 1 week before treatment and 1 week after treatment Previous primary outcome measure: Motor threshold values assessed using Transcranial Magnetic Stimulation (TMS) at 1 week before treatment, 4 weeks after treatment initiation and 1 week after treatment completion | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/05/2019: 1. Quality of life assessed using the Barthel Index (BI) scale answered by the patient or caregiver. 2. Stage of motor recovery assessed by the therapist using Brunnstrom's Recovery Stages (BRS) while observing the patient engage in small tasks suggested by Brunnstrom in the scale using the affected upper limb All the evaluations will take place 1 week before treatment and 1 week after treatment completion. Previous secondary outcome measures as of 13/03/2019: 1. Quality of life assessed using the Stroke Specific Quality of Life (SSQOL) scale answered by the patient or caregiver 2. Transcranial Magnetic Stimulator motor threshold (MT) presence or absence of stimulation of both upper limbs 3. Stage of motor recovery assessed by the therapist using Brunnstrom's Recovery Stages (BRS) while observing the patient engage in small tasks suggested by Brunnstrom in the scale using the affected upper limb All the evaluations will take place 1 week before treatment and 1 week after treatment completion. Previous secondary outcome measures: 1. Quality of life assessed using the Stroke Specific Quality of Life (SSQOL) scale answered by the patient or caregiver 2. Upper limb function assessed by the therapist using the Fugl-Meyer for Upper Extremity (FMA-UE) scale while patient is sitting down 3. Stage of motor recovery assessed by the therapist using Brunnstrom's Recovery Stages (BRS) while observing the patient engage in small tasks suggested by Brunnstrom in the scale using the affected upper limb All the evaluations will take place 1 week before treatment, 4 weeks after treatment initiation and 1 week after treatment completion. | — |
Countries
China
Outcome results
None listed