An interventional study of balance-focus exercise programe in Parkinson Disease, Gait Disorders and Gait Balance, sponsored by Ministry of Health, Kuwait. Not yet recruiting at 1 site in Kuwait. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by Ministry of Health, Kuwait · Not applicable, Interventional, and Treatment
Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired. The purpose of this study is determining effectiveness of comprehensive, balanced-focused exercise programme in controlling the activation of Solus-muscle in people with Parkinson disease. We hypothesise that balance-focus exercise programe could improve Solus-muscle activation during GI.
study type: this is a parallel group prospective (10 weeks) randomised single-blinded controlled trial conduct in Kuwait.
Participant: People with Parkinson, who met the inclusion criteria.
Parkinson's Disease (PD), a neurodegenerative disorder characterised by motor dysfunction . The basal ganglia play a significant role in regulating muscle excitation, and its dysfunction in PD leads to abnormal activation patterns in muscles such as the soleus, crucial for walking. This contributes to symptoms like bradykinesia, resulting in slower movement, shuffling gait, and difficulty initiating walking. Prolonged activation of the plantar flexor muscles, especially the soleus, disrupts the forward momentum needed for normal walking.
Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. The GI process requires a propulsive force to move the body across a distance (from a bipedal stance to repeating gait cycles) while maintaining postural stability. Thus, GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired.
Any modification to the GI program could affect postural stability and the velocity of the movement and any impairment in muscle activation of the lower limb will interfere with the GI process, .
This underscores the significance of the altered muscle excitation pattern observed in PWP and its potential impact on motor control. This imbalance can contribute to the prolonged muscle activation times and differential speed changes observed in muscle activation patterns.
Bradykinesia is a slow movement during the execution of common physical activities, such as the activities of daily living (ADL). That could be because PWP tend to keep the plantar flexor muscles mainly (solus) contracted for longer time. This prolonged muscle activity interferes with the gravity-assisted forward rotation of the body resulting adverse affects on the timing of subsequent events during gait initiation.
Therefore, therapies aimed at restoring the balance during GI may help improve motor control and balance in individuals, thus improve GI speed with Parkinson's disease.
Balance-focused rehabilitation strategies, including interactive exercises, are promising in addressing delays in GI. Several previous studies explored the effect of balance exercise of the GI in patients with Parkinson. For example, in a systematic exploration of cueing therapy's impact on gait and balance in individuals with Parkinson's disease, revealed its efficacy. This approach, the cueing therapy was highlighted as a promising intervention for addressing gait and balance challenges in Parkinson's disease. Another significant approach for functional rehabilitation is the utilization of balance boards, as underscored by. Investigating the effectiveness of a Wii Fit™-based balance board exercise program in the elderly population. Consequently, Mhatre et al. concluded that the Wii Fit™ balance board exercise program represents a valuable tool for augmenting balance and mitigating fall risk among older adults. In the context of functional rehabilitation, these interventions, particularly cueing therapy and balance board exercises, signify promising avenues for improving motor function and addressing challenges associated with gait and balance. Consideration of these therapeutic approaches is crucial for devising comprehensive and effective rehabilitation strategies tailored to the unique needs of individuals undergoing functional rehabilitation.
However, there is a need for further research to explore effective rehabilitation strategies tailored to different disease severity levels. To improve the maintenance and rehabilitation of community walking ability in PWP, there is a need to understand the details of the kinematics, as well as the muscle activation characteristics during while GI.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Ministry of Health, Kuwait is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Control Group: Conventional Physiotherapy - Participants will receive standard physiotherapy interventions targeting gait and motor symptoms. Conventional Physiotherapy will include: * Balance and Postural Training, (e.g. bridging and rolling exercise), * Flexibility and Range of Motion (e.g. upper limb exercise include shoulder, elbow and wrist movements, lower limb exercise including hip, knee and ankle movement) * Strength Training focus on anti-gravity muscles (e.g. squatting, body-weight strengthening exercise) * Functional Mobility Training (e.g. Sit-to-stand practice and stairs training * gait training (e.g. Practice heel-to-toe walking, emphasize large, exaggerated steps, use visual cues and auditory cues, turn training: wide arc turning to avoid freezing, treadmill walking with therapist supervision) * home program.
Participants will receive comprehensive balance-focused exercise programme integrated into conventional physiotherapy. The participants will be engaged in supervised sessions (by physiotherapists) of interactive balanced exercises focusing on improving balance, cognition, and coordination. The comprehensive balance-focused exercise programme will consist of motor tasks using interactive balance device to facilitate postural stability and weight-shifting control.
Other: balance-focus exercise programe
participants in the experimental group will receive balance-focused exercise programe integrated into conventional physiotherapy programe provided to people with parkinson.
weight
weight of the person in KG
Time frame: baseline
height
the height of the person in CM
Time frame: baseline
gait analysis
• Three-dimensional motion analysis:Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.
Time frame: baseline
Gait Analysis
Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.
Time frame: 6 weeks
gait analysis
Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.
Time frame: 10 weeks
• electromyography (EMG)
Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).
Time frame: baseline
electromyography EMG
Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).
Time frame: 6 weeks
electromyography EMG
Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).
Time frame: 10 weeks
Parkinson severity scale (PDQ-39)
To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.
Time frame: baseline
Parkinson severity scale PDQ-39
To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.
Time frame: 6 weeks
Parkinson severity scale PDQ-39
To evaluate the impact of Parkinson's disease on different dimensions of a patient's life and monitor changes over time.
Time frame: 10 weeks
Timed Up and Go test (TUG)
widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment
Time frame: baseline
Timed Up and Go test TUG
widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment
Time frame: 6 weeks
time up and go TUG
widely used clinical test to assess a person's mobility, balance, walking ability, and fall risk. It is especially useful in older adults and individuals with neurological or musculoskeletal impairment
Time frame: 10 weeks
PITTSBURGH rehabilitation participation scale
a clinician-rated tool used to measure a patient's level of participation in inpatient rehabilitation therapy sessions. It focuses on observed engagement, effort, and motivation.
Time frame: 6 weeks
patient satisfaction
in response to the question how satisfied are you with the results of physiotherapy treatment? Patient will be asked tp grade their level of satisfaction on 5 points liked scale (1. Not at all satisfied, 2. Dissatisfied, 3. Natural, 4. Satisfied, 5. Very satisfied)
Time frame: 6 weeks
Plan to share: Undecided — IPD collected in this research will be owned by the ministry of health in Kuwait and restrictions apply to the availability of these data publicly. however, IPD can be available from authors upon resonable request and with permission of the ministry of health
Start is estimated for Jan 2026; primary completion for Dec 2027, 23 months later.
Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 23 months is close to that.
Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Kuwait