Hip FractureNCT07323147
Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture
A study testing Exoskeleton and Conventional rehabilitation program in people with Hip Fracture and Geriatrics, run by Hai bao at 1 site in China.
Trial summary
With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Hip Fracture, Geriatrics, Lower Extremity Dysfunction
- What is being tested?
- Exoskeleton and Conventional rehabilitation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older, regardless of gender.
- Diagnosed with a unilateral hip fracture resulting from low-energy trauma by imaging (X-ray/CT), and having undergone surgical treatment (internal fixation or arthroplasty).
- The participant or their legal guardian understands and agrees to participate in the clinical trial and is willing to provide voluntary written informed consent.
Who cannot join
- Life expectancy of less than 6 months.
- History of neurological disorders such as prior stroke, spinal cord injury, Parkinson's disease, or myasthenia gravis.
- Severe joint contractures, deformities, or heterotopic ossification in the lower limbs that would prevent proper device fitting.
- Body weight exceeding the device's maximum load capacity (>100 kg).
- Height outside the adjustable range of the device.
- Presence of a pathological fracture or multiple fragility fractures.
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- Presence of severe osteoarthritis or trauma in the contralateral lower limb that significantly impairs function.
- Comorbidities including active malignancy or systemic infection.
- Comorbidities such as thromboembolic disease in the lower limbs, pneumonia, or pressure injuries (bedsores).
- Comorbidities affecting rehabilitation capacity, including unstable angina, heart failure, severe sequelae of stroke, severe chronic obstructive pulmonary disease (COPD), or severe hepatic/renal dysfunction.
- Poor compliance, cognitive impairment preventing cooperation, or diagnosed psychiatric disorders such as depression or anxiety.
- Participation in any other clinical trial within the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Jishuitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100035
About this study
Official title: Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture: A Multicenter, Open-Label, Randomized Controlled Clinical Trial
With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.
- Conditions
- Hip Fracture, Geriatrics, Lower Extremity Dysfunction, Postoperative Rehabilitation, Gait Disorders
- Being tested
- Exoskeleton, Conventional rehabilitation program
- Keywords
- Exoskeleton Robot, Robotic Rehabilitation, Wearable Devices, Randomized Controlled Trial, Multicenter Study, Recovery of Function, Harris Hip Score
- Medical subject headings
- Hip Fractures, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExoskeletonDevice
- Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed duration.
- Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range.
- Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient actively attempts to execute joint flexion and extension movements. The exoskeleton provides adjustable assistance levels proportionate to the patient's muscular capacity.
Conventional rehabilitation programOther
- Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises;
- Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, along with concurrent strength training for both upper limbs and the unaffected lower limb;
- Depending on the patient's rehabilitation progress, training in position transfer, standing, and gait will be initiated; traditional physical rehabilitation modalities such as therapeutic cycling, electrical stimulation, and medium-frequency therapy devices may also be incorporated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Training with exoskeleton+Conventional rehabilitation program Receives: Device: Exoskeleton |
| Control Group | Active comparator | Conventional rehabilitation program Receives: Other: Conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score
Assessed using the Harris Hip Score (HHS), a disease-specific instrument widely used for evaluating outcomes following hip surgery or in hip pathology. The scale assesses the patient across four domains: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). The total score ranges from 0 to 100 points. A higher score indicates better hip joint function and less disability. The reported value is the total HHS score (points).
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2).
Secondary outcomes (7)
Berg Balance Scale
Assessed using the Berg Balance Scale. This scale consists of 14 items that evaluate static and dynamic balance abilities (e.g., standing, turning, picking up objects). Each item is scored from 0 to 4 points. The total score ranges from 0 to 56 points. A higher score indicates better balance function. The reported value is the total scale score (points).
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2)
Timed Up and Go Test
The time required for the subject to rise from a chair, walk 3 meters, turn around, walk back, and sit down is recorded. The reported value is the time to complete the test (seconds). A shorter time indicates better functional mobility.
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2).
6-Minute Walk Test
The maximum distance a subject can walk on a flat surface within 6 minutes is measured. The reported value is the total walking distance (meters). A greater distance indicates better walking endurance.
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2).
Visual Analogue Scale (VAS)
Assessed using the Visual Analogue Scale (VAS) to evaluate the subject's average pain intensity over the past 24 hours. Subjects mark their pain level on a 10-cm line anchored with "no pain" (0) and "worst pain imaginable" (10). The reported value is the distance from the start point to the mark (centimeters). A higher score indicates more severe pain.
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2).
Range of Motion Measurement
The active range of flexion of the affected hip joint is measured using a universal goniometer. The reported value is the angle of flexion (degrees). A greater angle indicates better joint mobility function.
Measured: 1-month post-intervention (T1), 3-month post-intervention (T2).
Psychological Assessment
Assessed using the anxiety subscale (HADS-A) of the Hospital Anxiety and Depression Scale (HADS). This subscale comprises 7 items, each scored from 0 to 3 points. The total score ranges from 0 to 21 points. A higher score indicates more severe anxiety symptoms. The reported value is the total subscale score for anxiety (points).
Measured: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).
Proteomics Analysis
Proteomic analysis is performed on fasting venous blood samples to compare protein expression profiles between different time points (T1/T2 vs. T0) and between groups (intervention vs. control). The reported value is the number of statistically significant differentially expressed proteins identified under set significance thresholds (e.g., p<0.05 and fold change >1.5).
Measured: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The target total sample size is 86 participants. A competitive enrollment model will be used, with no pre-set quota for individual study sites. All participating centers will collectively compete to achieve the overall recruitment target.
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hai bao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hai bao, Beijing Jishuitan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323147
- Sponsor's protocol ID
- JST-IIT-2025086
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be publicly shared due to ethical and privacy considerations, institutional data use agreements, and current resource limitations. Access may be reconsidered in compliance with future funder or publisher requirements. For inquiries, please contact the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture: A Multicenter, Open-Label, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07323147
- Acronym / sponsor ID
- JST-IIT-2025086
- Conditions
- Hip Fracture, Geriatrics, Lower Extremity Dysfunction, Postoperative Rehabilitation, Gait Disorders
- Keywords
- Exoskeleton Robot, Robotic Rehabilitation, Wearable Devices, Randomized Controlled Trial, Multicenter Study, Recovery of Function, Harris Hip Score
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Hai baoUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- 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.
With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The target total sample size is 86 participants. A competitive enrollment model will be used, with no pre-set quota for individual study sites. All participating centers will collectively compete to achieve the overall recruitment target.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: ExoskeletonTraining with exoskeleton+Conventional rehabilitation program |
| Control Group | Active comparator | Other: Conventional rehabilitation programConventional rehabilitation program |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 65 years or older, regardless of gender.
- Diagnosed with a unilateral hip fracture resulting from low-energy trauma by imaging (X-ray/CT), and having undergone surgical treatment (internal fixation or arthroplasty).
- The participant or their legal guardian understands and agrees to participate in the clinical trial and is willing to provide voluntary written informed consent.
Key exclusion criteria (12 listed)
- Life expectancy of less than 6 months.
- History of neurological disorders such as prior stroke, spinal cord injury, Parkinson's disease, or myasthenia gravis.
- Severe joint contractures, deformities, or heterotopic ossification in the lower limbs that would prevent proper device fitting.
- Body weight exceeding the device's maximum load capacity (>100 kg).
- Height outside the adjustable range of the device.
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 |
|---|---|---|
| Exoskeleton1. Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed duration. 2. Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range. 3. Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient actively attempts to execute joint flexion and extension movements. The exoskeleton provides adjustable assistance levels proportionate to the patient's muscular capacity. | Device | Intervention Group |
| Conventional rehabilitation program1. Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises; 2. Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, along with concurrent strength training for both upper limbs and the unaffected lower limb; 3. Depending on the patient's rehabilitation progress, training in position transfer, standing, and gait will be initiated; traditional physical rehabilitation modalities such as therapeutic cycling, electrical stimulation, and medium-frequency therapy devices may also be incorporated. | Other | Control Group |
Primary outcome
Harris Hip Score
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).
Assessed using the Harris Hip Score (HHS), a disease-specific instrument widely used for evaluating outcomes following hip surgery or in hip pathology. The scale assesses the patient across four domains: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). The total score ranges from 0 to 100 points. A higher score indicates better hip joint function and less disability. The reported value is the total HHS score (points).
7 secondary outcomes
Berg Balance Scale
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2)
Timed Up and Go Test
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).
6-Minute Walk Test
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).
Visual Analogue Scale (VAS)
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).
Range of Motion Measurement
Time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).
Psychological Assessment
Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).
Proteomics Analysis
Time frame: Baseline (T0), 1-month post-intervention (T1), 3-month post-intervention (T2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be publicly shared due to ethical and privacy considerations, institutional data use agreements, and current resource limitations. Access may be reconsidered in compliance with future funder or publisher requirements. For inquiries, please contact the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton and Conventional rehabilitation program in people with Hip Fracture and Geriatrics, run by Hai bao at 1 site in China.
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 3 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 23 Jan 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Harris Hip Score (time frame: 1-month post-intervention (T1), 3-month post-intervention (T2).). 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 23 Jan 2026.