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The effects of reverse pedaling training on stiff knee gait pattern and Electromyography (EMG) – Electroencephalogram (EEG) coherence of lower extremity in patients with stroke

The effects of reverse pedaling training on stiff knee gait pattern and Electromyography (EMG) – Electroencephalogram (EEG) coherence of lower extremity in patients with stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001296426
Enrollment
80
Registered
2016-09-14
Start date
2016-04-02
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Stiff-knee gait (SKG) is a common abnormal gait pattern in stroke patients. The manual therapy and the modality therapy were commonly intervention methods to improve SKG. But the effects of those methods of treatment are not very satisfactory. The research indicated that only biceps femoris (BF), semimembranosus (SM), and rectus femoris (RF) exhibited different activity responses during different directions pedaling (forward or backward pedaling). After review recent literatures, several studies compared backward and forward pedaling in normal adults. However, the effects of different pedaling exercise in SKG stroke patients are still unclear. Therefore, our further study is to investigate the new treatment to apply this to clinical setting. 20 healthy adults and 60 chronic SKG stroke subjects will be recruited in this study. We will be a three-stage research project to investigate this issue. Twenty healthy adults in the first section, they will receive once assessment, including walking test and pedaling test. We will record bilateral rectus femoris and hamstrings EMG, range of motion of bilateral knee joint, gait performance during walking, and collect EEG-EMG signals for calculating coherence during forward and backward pedaling (30rpm, 45rpm, 60rpm) testing. The purpose is to establish a database of gait parameters and the situation of muscles activation during walking and EEG-EMG coherence during forward and backward pedaling (30rpm, 45rpm, 60rpm) testing. In the second section, we will explore the EEG-EMG coherence in stroke patients when they execute fast speed (45rpm) with two kinds of pedaling direction testing. Moreover, we will compare the differences between the control and experimental groups. Before pedaling test, twenty stroke patients will be receiving a Brunnstrom motor recovery assessment and range of motion of bilateral knee joint. If they meet stiff knee criteria before they can participate in the study. The pedaling test the same with the first section. The third section is mainly to discuss the impacts of the pedaling training with different directions on stiff knee walking pattern of stroke patients. Forty SKG stroke subjects will be randomly assigned to forward pedaling (FP) and the backward pedaling (BP) groups. All stroke participants will be trained by 30 minutes forward or backward 45rpm pedaling exercise follow 20 minutes traditional physical therapy for 3 times per week for 4 weeks. Before and after 4weeks intervention, all SKG stroke patients will receive the twice assessment. The first assessment will perform by walking test (bilateral rectus femoris and hamstrings EMG), the range of motion of bilateral knee joint, gait performance and collect EEG-EMG signals during forward and backward pedaling (45rpm) testing. Secondary assessment will perform by clinical assessments. We will compare the differences between the before and after training.

Interventions

In the first part of the study, 20 healthy participants only receive once assessment that includes pedaling test and walking test. The pedaling test includes two directions (forward and backward) combine three kinds of revolution (30, 45, 60 RPM). Each direction combines one type revolution will ride 60 seconds, total perform three times. Healthy participants do not receive any bicycle training or conventional physical therapy. In the second part of the study, 20 stroke patients only receive o

In the first part of the study, 20 healthy participants only receive once assessment that includes pedaling test and walking test. The pedaling test includes two directions (forward and backward) combine three kinds of revolution (30, 45, 60 RPM). Each direction combines one type revolution will ride 60 seconds, total perform three times. Healthy participants do not receive any bicycle training or conventional physical therapy. In the second part of the study, 20 stroke patients only receive once assessment that includes clinical assessment, pedaling test and walking test. The clinical assessment includes Brunnstrom assessment of lower extremity, Fugl-Meyer assessment of lower extremity, 5 repetitions sit to stand test, and Time Up and Go Test. The pedaling test includes two directions (forward and backward) combine 45 RPM. Each direction combines 45RPM will ride 60 seconds, total perform three times. Subjects in this part, they do not receive any bicycle training or conventional physical therapy. In the third part of the study, we will recruit 40 stroke patients. They will be randomly assigned to forward pedaling group (FW) or backward pedaling group (BW). We will use bicycle training combine traditional physical therapy for intervention. Before and after 4 weeks intervention, they will accept separately an assessment. The assessment is including clinical evaluation, pedaling test and walking test. Forward pedaling training will be treated as a control group. Backward pedaling is the intervention being assessed. The results of BW pedaling group will be compared with FW group. Each intervention includes 30mins FW or BW pedaling training combine 45RPM (30-minute intervention includes 5mins warm up and 5mins cool down) and traditional physical therapy 20mins. The intervention will be executive 3 times per week, total 4 weeks. Traditional physical therapy focuses on weight shifting, affected side lower limb weight bearing and walking practice. This study carried out by physiotherapists in the physical therapy laboratory at National Yang-Ming University. (The physiotherapist must have at least 2 years of clinical experience and qualified physiotherapist.) We will provide individually and face to face training.

Sponsors

National Yang-Ming University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

20 participants in control group met the following inclusion criteria: (1) age between the 40 to 65 years old; (2) could tolerate sitting on a bicycle seat at least one hour and complete the pedaling activity; (3) no other orthopedics or cardiovascular disease that could prohibit the bicycle exercise execution; (4)no epilepsy or take epileptic drugs last six months. 20 stroke participants in the assessment only group and 40 participants in the experimental group are met the following inclusion criteria: (1) age between the 40 to 65 years old; (2) Hemisphere stroke more than 6 months with hemiplegia; (3) Lower extremity Brunnstrom motor recovery stage at 3-4 (focus on still have stiff knee problem); (4) must comply with Stiff-knee gait screening criteria; (5) Can able to walk >3 m with or without a walking aid or orthosis; (6) could tolerate sitting on a bicycle seat at least one hour and complete the pedaling activity; (7) no other orthopedics or cardiovascular disease that could prohibit the bicycle exercise execution; (8) Mini-Mental State Examination equal or more than 24, can to obey the orders; (9) no epilepsy or take epileptic drugs last six months.

Exclusion criteria

if they have other orthopedics or cardiovascular disease if they have epilepsy or take epileptic drugs last six months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026